<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01732107</url>
  </required_header>
  <id_info>
    <org_study_id>GU12-157</org_study_id>
    <nct_id>NCT01732107</nct_id>
  </id_info>
  <brief_title>Dovitinib in BCG Refractory Urothelial Carcinoma With FGFR3 Mutations or Over-expression</brief_title>
  <official_title>A Phase II Trial of Dovitinib in Bacillus Calmette-Guerin(BCG) Refractory Urothelial Carcinoma Patients With Tumor Fibroblast Growth Factor Receptor 3(FGFR3) Mutations or Over-expression: Hoosier Cancer Research Network GU12-157</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Noah Hahn, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hoosier Cancer Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoosier Cancer Research Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will assess the 6-month complete response rate and toxicity profile of oral&#xD;
      dovitinib therapy in BCG-refractory urothelial carcinoma patients with tumors with FGFR3&#xD;
      mutations or over-expression who are ineligible for or refusing cystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE: This is a multi-center study.&#xD;
&#xD;
        -  Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
           Day 12 assessments are intended to be performed on the last dosing day of the 2nd week&#xD;
           in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last&#xD;
           dosing day of the 4th week in cycle 1 and cycle 2.&#xD;
&#xD;
        -  Standard of Care: Cystoscopy with tumor biopsy, bladder biopsy, urine cytology&#xD;
&#xD;
        -  Physician discretion: Anti-emetic medications and/or colony stimulating growth factors&#xD;
&#xD;
      ECOG performance status 0 - 2&#xD;
&#xD;
      Hematopoietic:&#xD;
&#xD;
        -  White blood cell count (WBC) &gt; 3.0 K/mm3&#xD;
&#xD;
        -  Absolute neutrophil count (ANC) ≥ 1.5 K/mm3&#xD;
&#xD;
        -  Platelets ≥ 100 K/mm3&#xD;
&#xD;
        -  Hemoglobin (Hgb) ≥ 9 g/dL&#xD;
&#xD;
      Hepatic:&#xD;
&#xD;
        -  Serum total bilirubin: ≤ 1.5 x Upper limit of normal (ULN)&#xD;
&#xD;
        -  Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3.0 x ULN&#xD;
&#xD;
      Renal:&#xD;
&#xD;
        -  Serum creatinine ≤ 1.5 x ULN or serum creatinine &gt; 1.5 - 3 x ULN if calculated&#xD;
           creatinine clearance (CrCl) is ≥ 30 mL/min using the Cockcroft-Gault equation&#xD;
&#xD;
      Cardiovascular:&#xD;
&#xD;
      No impaired cardiac function or clinically significant cardiac diseases, including any of the&#xD;
      following:&#xD;
&#xD;
        -  History or presence of serious uncontrolled ventricular arrhythmias&#xD;
&#xD;
        -  Clinically significant resting bradycardia&#xD;
&#xD;
        -  LVEF assessed by 2-D echocardiogram (ECHO) &lt; 50% or lower limit of normal (whichever is&#xD;
           higher) or multiple gated acquisition scan (MUGA), &lt; 45% or lower limit of normal&#xD;
           (whichever is higher)&#xD;
&#xD;
        -  Myocardial Infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG),&#xD;
           Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic&#xD;
           Attack (TIA), Pulmonary Embolism (PE)within 6 months prior to starting study drug&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Development of dovitinib was stopped.&#xD;
  </why_stopped>
  <start_date type="Actual">March 2013</start_date>
  <completion_date type="Actual">March 6, 2017</completion_date>
  <primary_completion_date type="Actual">March 6, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine 6-Month Complete Response Rate</measure>
    <time_frame>6 months</time_frame>
    <description>The 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine 1-Year Relapse-Free Survival Rate</measure>
    <time_frame>12 months</time_frame>
    <description>The 1-year relapse free survival rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors at 12 months of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine Rate of Progression to Muscle-Invasive Stage</measure>
    <time_frame>12 months</time_frame>
    <description>The rate of progression to muscle-invasive stage for dovitinib is defined as the proportion of patients with clinical or pathologic progression to muscle-invasive stages (i.e., T2-T4) at any time point on study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine 3-Month and 6-Month Partial Response Rates</measure>
    <time_frame>6 months</time_frame>
    <description>The 3- and 6-month partial response rates are defined as the proportion of patients treated with persistent but reduced T-stage tumors on post-therapy TURBT (i.e., T1 ≥ Ta; T1+Tis ≥ T1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterize Treatment-related Toxicity Rates</measure>
    <time_frame>12 months</time_frame>
    <description>Treatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All grade 3-4 adverse events and other adverse events occurring in more than 20% of patients are reported.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Characterize Pre- and Post-treatment Bladder Tumor FGFR Pathway Phosphorylation Changes.</measure>
    <time_frame>12 months</time_frame>
    <description>Pre- and post-treatment bladder tumor FGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: fibroblast growth factor receptors (FGFR3, pFGFR3), vascular endothelial growth factor receptors (VEGFR2, pVEGFR2), fibroblast growth factor receptor substrates (2FRS2, pFRS2), extracellular signal-regulated kinases (ERK), phosphorylated extracellular signal-related kinase (pERK).</description>
  </other_outcome>
  <other_outcome>
    <measure>Characterize Associations Between Pre-treatment Germline, FGFR Single-nucleotide Polymorphisms (SNPs) and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.</measure>
    <time_frame>12 months</time_frame>
    <description>Pre-treatment germline FGFR SNPs will be assessed by testing extracted Deoxyribonucleic acid (DNA) from patient peripheral blood mononuclear cells (PBMC's) (collected prior to initiating dovitinib therapy) with validated commercial probes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characterize Pre- and Post-treatment VEGFR Pathway Phosphorylation Changes as Assessed by Bladder Tumor Tissue Immunohistochemistry.</measure>
    <time_frame>12 months</time_frame>
    <description>Pre- and post-treatment bladder tumor VEGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: FGFR3, pFGFR3, VEGFR2, pVEGFR2, FRS2, pFRS2, ERK, pERK.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characterize Associations Between Pre-treatment Germline VEGFR SNPs and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.</measure>
    <time_frame>12 months</time_frame>
    <description>Pre-treatment germline VEGFR SNPs will be assessed by testing extracted DNA from patient PBMC's (collected prior to initiating dovitinib therapy) with validated commercial probes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characterize Associations Between Post-treatment Hypertension, 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.</measure>
    <time_frame>12 months</time_frame>
    <description>Hypertension will be defined as a systolic blood pressure (SBP) of &gt; 140 mmHg or a diastolic blood pressure (DBP) of &gt; 90 mm Hg recorded at any time after dovitinib therapy is initiated.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characterize Concordance Rates Between UC Patient Detected Tumor, Urine, and Circulating Free Plasma FGFR3 Mutations.</measure>
    <time_frame>12 months</time_frame>
    <description>Presence of FGFR3 mutations within patient free plasma will be assessed by polymerase chain reaction (PCR) amplification of the target regions and sequencing.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.</measure>
    <time_frame>12 months</time_frame>
    <description>Post-treatment bladder tissue dovitinib concentrations will be assessed by TURBT fresh frozen tissue obtained at the 3-month cystoscopy</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Dovitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dovitinib</intervention_name>
    <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
    <arm_group_label>Dovitinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed early stage urothelial carcinoma of the bladder defined as&#xD;
             Ta, T1, or Tis stage.&#xD;
&#xD;
          -  Presence of either an FGFR3 mutation or FGFR3 over-expression within bladder tumor&#xD;
             tissue.&#xD;
&#xD;
          -  Documented BCG-refractory disease defined as failure to achieve a tumor free state&#xD;
             after at least 2 prior induction courses of intravesical BCG therapy.&#xD;
&#xD;
          -  Medically unfit to undergo cystectomy or electively choosing to forego cystectomy&#xD;
&#xD;
          -  Patients who give a written informed consent obtained according to local guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with muscle-invasive (i.e. T2, T3, T4), locally advanced non-resectable, or&#xD;
             metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained&#xD;
             within 28 days prior to study registration.&#xD;
&#xD;
          -  Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive&#xD;
             urothelial carcinoma.&#xD;
&#xD;
          -  Patients with another primary malignancy within 3 years prior to starting study drug,&#xD;
             with the exception of adequately treated in-situ carcinoma of the uterine cervix,&#xD;
             clinically localized prostate cancer, biochemically relapsed non-metastatic prostate&#xD;
             cancer (i.e., PSA only disease), or skin cancer (such as basal cell carcinoma,&#xD;
             squamous cell carcinoma, or non-melanomatous skin cancer)&#xD;
&#xD;
          -  Patients who have received the last administration of an anti-cancer therapy including&#xD;
             chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting&#xD;
             study drug, or who have not recovered from the side effects of such therapy&#xD;
&#xD;
          -  Patients who have received prior VEGFR-targeted or FGFR-targeted agents (i.e.,&#xD;
             sunitinib, pazopanib, sorafenib, bevacizumab, axitinib, etc.).&#xD;
&#xD;
          -  Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have&#xD;
             not recovered from radiotherapy toxicities&#xD;
&#xD;
          -  Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or&#xD;
             intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting&#xD;
             study drug, or patients who have had minor procedures (i.e., TURBT), percutaneous&#xD;
             biopsies or placement of vascular access device ≤ 1 week prior to starting study drug,&#xD;
             or who have not recovered from side effects of such procedure or injury&#xD;
&#xD;
          -  Uncontrolled hypertension defined by a systolic blood pressure (SBP) ≥ 160 mm Hg&#xD;
             and/or d iastolic blood pressure (DBP) ≥ 100 mm Hg, with or without anti-hypertensive&#xD;
             medication(s)&#xD;
&#xD;
          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly&#xD;
             alter the absorption of dovitinib (e.g., ulcerative diseases, uncontrolled nausea,&#xD;
             vomiting, diarrhea, malabsorption syndrome, or small bowel resection)&#xD;
&#xD;
          -  Cirrhosis, chronic active hepatitis or chronic persistent hepatitis&#xD;
&#xD;
          -  Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not&#xD;
             mandatory)&#xD;
&#xD;
          -  Patients who are currently receiving anti-coagulation treatment with therapeutic doses&#xD;
             of warfarin. Full-dose anti-coagulation with low molecular weight heparin is&#xD;
             permitted.&#xD;
&#xD;
          -  Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g.,&#xD;
             active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable&#xD;
             safety risks or compromise compliance with the protocol&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Women of child-bearing potential, who are biologically able to conceive, not employing&#xD;
             two forms of highly effective contraception. Highly effective contraception must be&#xD;
             used throughout the trial and up to 8 weeks after the last dose of study drug (e.g.&#xD;
             male condom with spermicidal; diaphragm with spermicide; intra-uterine device). Oral,&#xD;
             implantable, or injectable contraceptives that may be affected by cytochrome P450&#xD;
             interactions are not considered effective for this study. Women of child-bearing&#xD;
             potential, defined as sexually mature women who have not undergone a hysterectomy or&#xD;
             who have not been naturally postmenopausal for at least 12 consecutive months (i.e.,&#xD;
             who has had menses any time in the preceding 12 consecutive months), must have a&#xD;
             negative serum pregnancy test ≤ 14 days prior to starting study drug.&#xD;
&#xD;
          -  Fertile males not willing to use contraception, as stated above&#xD;
&#xD;
          -  Patients unwilling or unable to comply with the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noah Hahn, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Hoosier Cancer Research Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Melvin and Bren Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center Extramural Research Program</name>
      <address>
        <city>Rockledge</city>
        <state>Pennsylvania</state>
        <zip>19046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.hoosieroncologygroup.org</url>
    <description>Hoosier Oncology Group Website</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>July 25, 2018</results_first_submitted>
  <results_first_submitted_qc>July 25, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 22, 2018</results_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hoosier Cancer Research Network</investigator_affiliation>
    <investigator_full_name>Noah Hahn, M.D.</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>Dovitinib</keyword>
  <keyword>FGFR3 Mutations</keyword>
  <keyword>BCG-Refractory Urothelial Carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Transitional Cell</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 9, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT01732107/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dovitinib</title>
          <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dovitinib</title>
          <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" lower_limit="57" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Determine 6-Month Complete Response Rate</title>
        <description>The 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Determine 6-Month Complete Response Rate</title>
          <description>The 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Determine 1-Year Relapse-Free Survival Rate</title>
        <description>The 1-year relapse free survival rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors at 12 months of follow-up.</description>
        <time_frame>12 months</time_frame>
        <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Determine 1-Year Relapse-Free Survival Rate</title>
          <description>The 1-year relapse free survival rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors at 12 months of follow-up.</description>
          <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Determine Rate of Progression to Muscle-Invasive Stage</title>
        <description>The rate of progression to muscle-invasive stage for dovitinib is defined as the proportion of patients with clinical or pathologic progression to muscle-invasive stages (i.e., T2-T4) at any time point on study.</description>
        <time_frame>12 months</time_frame>
        <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Determine Rate of Progression to Muscle-Invasive Stage</title>
          <description>The rate of progression to muscle-invasive stage for dovitinib is defined as the proportion of patients with clinical or pathologic progression to muscle-invasive stages (i.e., T2-T4) at any time point on study.</description>
          <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Determine 3-Month and 6-Month Partial Response Rates</title>
        <description>The 3- and 6-month partial response rates are defined as the proportion of patients treated with persistent but reduced T-stage tumors on post-therapy TURBT (i.e., T1 ≥ Ta; T1+Tis ≥ T1).</description>
        <time_frame>6 months</time_frame>
        <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Determine 3-Month and 6-Month Partial Response Rates</title>
          <description>The 3- and 6-month partial response rates are defined as the proportion of patients treated with persistent but reduced T-stage tumors on post-therapy TURBT (i.e., T1 ≥ Ta; T1+Tis ≥ T1).</description>
          <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Characterize Treatment-related Toxicity Rates</title>
        <description>Treatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All grade 3-4 adverse events and other adverse events occurring in more than 20% of patients are reported.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterize Treatment-related Toxicity Rates</title>
          <description>Treatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All grade 3-4 adverse events and other adverse events occurring in more than 20% of patients are reported.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fatigue (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Constitutional (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Constitutional (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fall (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Hemmorage (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GERD (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GERD (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GERD (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anorexia (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anorexia (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight loss (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dysgeusia (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dysgeusia (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea/Emesis (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emesis (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other gastrointestinal (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other gastrointestinal (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stomatitis (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hand-foot syndrome (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hand-foot syndrome (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dry mouth (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other skin (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other skin (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bladder spasms (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other urinary (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other urinary (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infection (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hoarseness (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other pulmonary (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other pulmonary (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia/Myalgia (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia/Myalgia (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertriglyceridemia (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertriglyceridemia (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertriglyceridemia (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertriglyceridemia (Grade 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elevated alkaline phosphatase (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elevated alkaline phosphatase (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elevated GGT (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elevated GGT (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoalbuminemia (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoalbuminemia (Grade 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elevated lipase (Grade 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other metabolic (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anemia (Grade 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characterize Pre- and Post-treatment Bladder Tumor FGFR Pathway Phosphorylation Changes.</title>
        <description>Pre- and post-treatment bladder tumor FGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: fibroblast growth factor receptors (FGFR3, pFGFR3), vascular endothelial growth factor receptors (VEGFR2, pVEGFR2), fibroblast growth factor receptor substrates (2FRS2, pFRS2), extracellular signal-regulated kinases (ERK), phosphorylated extracellular signal-related kinase (pERK).</description>
        <time_frame>12 months</time_frame>
        <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterize Pre- and Post-treatment Bladder Tumor FGFR Pathway Phosphorylation Changes.</title>
          <description>Pre- and post-treatment bladder tumor FGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: fibroblast growth factor receptors (FGFR3, pFGFR3), vascular endothelial growth factor receptors (VEGFR2, pVEGFR2), fibroblast growth factor receptor substrates (2FRS2, pFRS2), extracellular signal-regulated kinases (ERK), phosphorylated extracellular signal-related kinase (pERK).</description>
          <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characterize Associations Between Pre-treatment Germline, FGFR Single-nucleotide Polymorphisms (SNPs) and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.</title>
        <description>Pre-treatment germline FGFR SNPs will be assessed by testing extracted Deoxyribonucleic acid (DNA) from patient peripheral blood mononuclear cells (PBMC's) (collected prior to initiating dovitinib therapy) with validated commercial probes.</description>
        <time_frame>12 months</time_frame>
        <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterize Associations Between Pre-treatment Germline, FGFR Single-nucleotide Polymorphisms (SNPs) and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.</title>
          <description>Pre-treatment germline FGFR SNPs will be assessed by testing extracted Deoxyribonucleic acid (DNA) from patient peripheral blood mononuclear cells (PBMC's) (collected prior to initiating dovitinib therapy) with validated commercial probes.</description>
          <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characterize Pre- and Post-treatment VEGFR Pathway Phosphorylation Changes as Assessed by Bladder Tumor Tissue Immunohistochemistry.</title>
        <description>Pre- and post-treatment bladder tumor VEGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: FGFR3, pFGFR3, VEGFR2, pVEGFR2, FRS2, pFRS2, ERK, pERK.</description>
        <time_frame>12 months</time_frame>
        <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterize Pre- and Post-treatment VEGFR Pathway Phosphorylation Changes as Assessed by Bladder Tumor Tissue Immunohistochemistry.</title>
          <description>Pre- and post-treatment bladder tumor VEGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: FGFR3, pFGFR3, VEGFR2, pVEGFR2, FRS2, pFRS2, ERK, pERK.</description>
          <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characterize Associations Between Pre-treatment Germline VEGFR SNPs and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.</title>
        <description>Pre-treatment germline VEGFR SNPs will be assessed by testing extracted DNA from patient PBMC's (collected prior to initiating dovitinib therapy) with validated commercial probes.</description>
        <time_frame>12 months</time_frame>
        <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterize Associations Between Pre-treatment Germline VEGFR SNPs and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.</title>
          <description>Pre-treatment germline VEGFR SNPs will be assessed by testing extracted DNA from patient PBMC's (collected prior to initiating dovitinib therapy) with validated commercial probes.</description>
          <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characterize Associations Between Post-treatment Hypertension, 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.</title>
        <description>Hypertension will be defined as a systolic blood pressure (SBP) of &gt; 140 mmHg or a diastolic blood pressure (DBP) of &gt; 90 mm Hg recorded at any time after dovitinib therapy is initiated.</description>
        <time_frame>12 months</time_frame>
        <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterize Associations Between Post-treatment Hypertension, 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.</title>
          <description>Hypertension will be defined as a systolic blood pressure (SBP) of &gt; 140 mmHg or a diastolic blood pressure (DBP) of &gt; 90 mm Hg recorded at any time after dovitinib therapy is initiated.</description>
          <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characterize Concordance Rates Between UC Patient Detected Tumor, Urine, and Circulating Free Plasma FGFR3 Mutations.</title>
        <description>Presence of FGFR3 mutations within patient free plasma will be assessed by polymerase chain reaction (PCR) amplification of the target regions and sequencing.</description>
        <time_frame>12 months</time_frame>
        <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterize Concordance Rates Between UC Patient Detected Tumor, Urine, and Circulating Free Plasma FGFR3 Mutations.</title>
          <description>Presence of FGFR3 mutations within patient free plasma will be assessed by polymerase chain reaction (PCR) amplification of the target regions and sequencing.</description>
          <population>Data for this outcome measure was neither collected or analyzed due to the early termination of the study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.</title>
        <description>Post-treatment bladder tissue dovitinib concentrations will be assessed by TURBT fresh frozen tissue obtained at the 3-month cystoscopy</description>
        <time_frame>12 months</time_frame>
        <population>9 subjects had sufficient tissue available to measure dovitinib tissue concentration</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.</title>
          <description>Post-treatment bladder tissue dovitinib concentrations will be assessed by TURBT fresh frozen tissue obtained at the 3-month cystoscopy</description>
          <population>9 subjects had sufficient tissue available to measure dovitinib tissue concentration</population>
          <units>nmol/L</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subject 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1603"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5813"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="812"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="726"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2483"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Duration of participation of the treatment portion of the study, up to six cycles (6 Months).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dovitinib</title>
          <description>Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.&#xD;
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAEv4</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>INTRACRANIAL HEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAEv4</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANEMIA</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>CARDIAC DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>CHEST PAIN - CARDIAC</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>CONDUCTION DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>SINUS BRADYCARDIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>EAR AND LABYRINTH DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HEARING IMPAIRED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>BLURRED VISION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>CATARACT</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>CONJUNCTIVITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>WATERING EYES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL DISTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>DIARRHEA</sub_title>
                <counts group_id="E1" events="15" subjects_affected="10" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>ESOPHAGEAL PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>FECAL INCONTINENCE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>FLATULENCE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>GASTROESOPHAGEAL REFLUX DISEASE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>ORAL PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>STOMACH PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>TOOTHACHE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="18" subjects_affected="11" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>FEVER</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>FLU LIKE SYMPTOMS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>MALAISE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HEPATOBILIARY DISORDERS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>EYE INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>PAPULOPUSTULAR RASH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>SKIN INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>BRUISING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>INJURY, POISONING AND PROCEDURAL COMPLICATIONS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>CHOLESTEROL HIGH</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>CREATININE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>GGT INCREASED</sub_title>
                <counts group_id="E1" events="12" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>INVESTIGATIONS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>LIPASE INCREASED</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>LYMPHOCYTE COUNT DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>SERUM AMYLASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>WEIGHT LOSS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>ANOREXIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HYPERCALCEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HYPERGLYCEMIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HYPERNATREMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HYPERTRIGLYCERIDEMIA</sub_title>
                <counts group_id="E1" events="17" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HYPOALBUMINEMIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HYPOKALEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESEMIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HYPOPHOSPHATEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>DYSARTHRIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>DYSGEUSIA</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>PARESTHESIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SENSORY NEUROPATHY</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>PSYCHIATRIC DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>BLADDER SPASM</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>CYSTITIS NONINFECTIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HEMATURIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>URINARY FREQUENCY</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>URINARY TRACT PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>URINARY URGENCY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>DYSPNEA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>HOARSENESS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>NASAL CONGESTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>SORE THROAT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>VOICE ALTERATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>DRY SKIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>PAIN OF SKIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>RASH ACNEIFORM</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>RASH MACULO-PAPULAR</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>SKIN AND SUBCUTANEOUS TISSUE DISORDERS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>SKIN HYPOPIGMENTATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>SKIN ULCERATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="27" subjects_affected="6" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Data Coordinator</name_or_title>
      <organization>Hoosier Cancer Research Network</organization>
      <phone>317-921-2050</phone>
      <email>jsmith@hoosiercancer.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01732107
org study id: GU12-157
nct id: NCT01732107
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This trial will assess the 6-month complete response rate and toxicity profile of oral
      dovitinib therapy in BCG-refractory urothelial carcinoma patients with tumors with FGFR3
      mutations or over-expression who are ineligible for or refusing cystectomy.
OUTLINE: This is a multi-center study.

        -  Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
           Day 12 assessments are intended to be performed on the last dosing day of the 2nd week
           in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last
           dosing day of the 4th week in cycle 1 and cycle 2.

        -  Standard of Care: Cystoscopy with tumor biopsy, bladder biopsy, urine cytology

        -  Physician discretion: Anti-emetic medications and/or colony stimulating growth factors

      ECOG performance status 0 - 2

      Hematopoietic:

        -  White blood cell count (WBC) > 3.0 K/mm3

        -  Absolute neutrophil count (ANC) ≥ 1.5 K/mm3

        -  Platelets ≥ 100 K/mm3

        -  Hemoglobin (Hgb) ≥ 9 g/dL

      Hepatic:

        -  Serum total bilirubin: ≤ 1.5 x Upper limit of normal (ULN)

        -  Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3.0 x ULN

      Renal:

        -  Serum creatinine ≤ 1.5 x ULN or serum creatinine > 1.5 - 3 x ULN if calculated
           creatinine clearance (CrCl) is ≥ 30 mL/min using the Cockcroft-Gault equation

      Cardiovascular:

      No impaired cardiac function or clinically significant cardiac diseases, including any of the
      following:

        -  History or presence of serious uncontrolled ventricular arrhythmias

        -  Clinically significant resting bradycardia

        -  LVEF assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (whichever is
           higher) or multiple gated acquisition scan (MUGA), < 45% or lower limit of normal
           (whichever is higher)

        -  Myocardial Infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG),
           Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic
           Attack (TIA), Pulmonary Embolism (PE)within 6 months prior to starting study drug
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine 6-Month Complete Response Rate
time frame: 6 months
description: The 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.
measure: Determine 1-Year Relapse-Free Survival Rate
time frame: 12 months
description: The 1-year relapse free survival rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors at 12 months of follow-up.
measure: Determine Rate of Progression to Muscle-Invasive Stage
time frame: 12 months
description: The rate of progression to muscle-invasive stage for dovitinib is defined as the proportion of patients with clinical or pathologic progression to muscle-invasive stages (i.e., T2-T4) at any time point on study.
measure: Determine 3-Month and 6-Month Partial Response Rates
time frame: 6 months
description: The 3- and 6-month partial response rates are defined as the proportion of patients treated with persistent but reduced T-stage tumors on post-therapy TURBT (i.e., T1 ≥ Ta; T1+Tis ≥ T1).
measure: Characterize Treatment-related Toxicity Rates
time frame: 12 months
description: Treatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All grade 3-4 adverse events and other adverse events occurring in more than 20% of patients are reported.
measure: Characterize Pre- and Post-treatment Bladder Tumor FGFR Pathway Phosphorylation Changes.
time frame: 12 months
description: Pre- and post-treatment bladder tumor FGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: fibroblast growth factor receptors (FGFR3, pFGFR3), vascular endothelial growth factor receptors (VEGFR2, pVEGFR2), fibroblast growth factor receptor substrates (2FRS2, pFRS2), extracellular signal-regulated kinases (ERK), phosphorylated extracellular signal-related kinase (pERK).
measure: Characterize Associations Between Pre-treatment Germline, FGFR Single-nucleotide Polymorphisms (SNPs) and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.
time frame: 12 months
description: Pre-treatment germline FGFR SNPs will be assessed by testing extracted Deoxyribonucleic acid (DNA) from patient peripheral blood mononuclear cells (PBMC's) (collected prior to initiating dovitinib therapy) with validated commercial probes.
measure: Characterize Pre- and Post-treatment VEGFR Pathway Phosphorylation Changes as Assessed by Bladder Tumor Tissue Immunohistochemistry.
time frame: 12 months
description: Pre- and post-treatment bladder tumor VEGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: FGFR3, pFGFR3, VEGFR2, pVEGFR2, FRS2, pFRS2, ERK, pERK.
measure: Characterize Associations Between Pre-treatment Germline VEGFR SNPs and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.
time frame: 12 months
description: Pre-treatment germline VEGFR SNPs will be assessed by testing extracted DNA from patient PBMC's (collected prior to initiating dovitinib therapy) with validated commercial probes.
measure: Characterize Associations Between Post-treatment Hypertension, 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.
time frame: 12 months
description: Hypertension will be defined as a systolic blood pressure (SBP) of > 140 mmHg or a diastolic blood pressure (DBP) of > 90 mm Hg recorded at any time after dovitinib therapy is initiated.
measure: Characterize Concordance Rates Between UC Patient Detected Tumor, Urine, and Circulating Free Plasma FGFR3 Mutations.
time frame: 12 months
description: Presence of FGFR3 mutations within patient free plasma will be assessed by polymerase chain reaction (PCR) amplification of the target regions and sequencing.
measure: Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
time frame: 12 months
description: Post-treatment bladder tissue dovitinib concentrations will be assessed by TURBT fresh frozen tissue obtained at the 3-month cystoscopy
arm group label: Dovitinib
arm group type: Experimental
description: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
intervention type: Drug
intervention name: Dovitinib
description: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
arm group label: Dovitinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Noah Hahn, M.D.
role: Study Chair
affiliation: Hoosier Cancer Research Network
facility: 
facility: 
facility: 
country: United States
url: http://www.hoosieroncologygroup.org
description: Hoosier Oncology Group Website
responsible party type: Sponsor-Investigator
investigator affiliation: Hoosier Cancer Research Network
investigator full name: Noah Hahn, M.D.
investigator title: Sponsor-Investigator
mesh term: Carcinoma
mesh term: Carcinoma, Transitional Cell
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 