<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/NCT02234596</url>
  </required_header>
  <id_info>
    <org_study_id>14-094</org_study_id>
    <nct_id>NCT02234596</nct_id>
  </id_info>
  <brief_title>Nintedanib in Patients With Advanced Esophagogastric Cancer</brief_title>
  <official_title>Phase II Trial of Nintedanib in Patients With Advanced Esophagogastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      This is a phase II study of Nintedanib in patients with metastatic or recurrent&#xD;
      esophagogastric cancer. The goal of the study is to evaluate the efficacy of Nintedanib, an&#xD;
      orally available triple kinase inhibitor targeting the receptors of the vascular endothelial&#xD;
      growth factor (VEGF), platelet derived growth factor (PDGF), and fibroblast growth factor&#xD;
      (FGF) receptor pathways.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2014</start_date>
  <completion_date type="Actual">April 22, 2020</completion_date>
  <primary_completion_date type="Actual">April 22, 2020</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>6-month Progression-free Survival (PFS)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>3 years</time_frame>
    <description>defined as both complete response (CR) and partial response (PR), as measured by RECIST response criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Evaluated for Toxicities</measure>
    <time_frame>3 years</time_frame>
    <description>The severity of adverse event should be classified and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Esophagogastric Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Nintedanib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nintedanib</intervention_name>
    <description>Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.</description>
    <arm_group_label>Nintedanib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically or cytologically MSKCC confirmed esophagogastric adenocarcinoma.&#xD;
&#xD;
          -  Metastatic diseases measurable or evaluable on a CT or MRI scan according to RECIST&#xD;
             1.1 criteria. Locally recurrent disease that is not amenable to potentially curative&#xD;
             surgery or radiation therapy is also allowed. Lesions must be ≥10mm in size. Recurrent&#xD;
             or metastatic disease within a prior radiation field is acceptable as long as the&#xD;
             disease has progressed in the radiation field by RECIST criteria.&#xD;
&#xD;
          -  Patients are allowed to have had a maximum of 1 prior chemotherapy regimen for&#xD;
             metastatic disease. Patients are allowed to have a maximum of two prior regimens if&#xD;
             they previously received neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for&#xD;
             their initial localized disease.&#xD;
&#xD;
          -  Patients aged 18 years or older.&#xD;
&#xD;
          -  Life expectancy of at least 6 months.&#xD;
&#xD;
          -  Karnofsky Performance Status (KPS) performance score ≥ 70%.&#xD;
&#xD;
          -  Patients must be able to reliably take and swallow oral medications.&#xD;
&#xD;
          -  Patients with prior deep vein thrombosis (DVT) or pulmonary embolism (PE) currently on&#xD;
             anticoagulation regimen will be permitted.&#xD;
&#xD;
          -  Adequate bone marrow, liver, and renal function as assessed by the following:&#xD;
&#xD;
          -  Hemoglobin ≥ 9.0 g/dL.&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) ≥ 1,500/mm3.&#xD;
&#xD;
          -  Platelet count ≥ 100,000/mm3.&#xD;
&#xD;
          -  Total bilirubin within normal limits, 0-1 mg/dL.&#xD;
&#xD;
          -  AST and ALT&lt; 1.5 times ULN. (For patients with liver involvement: AST and ALT≤ 2.5&#xD;
             ULN).&#xD;
&#xD;
          -  International normalized ratio (INR) &lt; 2, prothrombin time (PT) &lt; 20 sec, and partial&#xD;
             thromboplastin time (PTT) &lt; 55 sec .&#xD;
&#xD;
          -  Creatinine &lt; 1.5 x the ULN or GFR&lt;45 ml/min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HER-2 positive esophagogastric cancer. Patients with unknown HER2 status are&#xD;
             permitted.&#xD;
&#xD;
          -  Patients receiving any concurrent anticancer therapy or investigational agents with&#xD;
             the intention of treating esophagogastric cancer. Last prior therapy must have been&#xD;
             completed at least 2 weeks (14 days) prior to starting Nintedanib.&#xD;
&#xD;
          -  Concurrent radiotherapy is not permitted for disease progression on treatment on&#xD;
             protocol. However, symptomatic treatment for pre-existing non-target lesions would be&#xD;
             allowed with approval from the principal investigator.&#xD;
&#xD;
          -  Prior treatment with VEGFR inhibitor.&#xD;
&#xD;
          -  Brain metastases or leptomeningeal disease.&#xD;
&#xD;
          -  History of arterial thromboembolic (arterial blood clot) or hemorrhagic event with the&#xD;
             exception of patients with pulmonary embolism stable on an anticoagulation regimen.&#xD;
&#xD;
          -  Patients with a cerebrovascular accident or transient ischemic attack within the past&#xD;
             six months.&#xD;
&#xD;
          -  Patients on warfarin for any reason.&#xD;
&#xD;
          -  Patient with known pre-existing interstitial lung disease.&#xD;
&#xD;
          -  History or presence of clinically relevant cardiovascular abnormalities such as&#xD;
             uncontrolled hypertension, congestive heart failure, New York Heart Association (NYHA)&#xD;
             functional classification of 3, unstable angina or poorly controlled arrhythmia.&#xD;
             Myocardial infarction within 6 month prior to the study entry.&#xD;
&#xD;
          -  Patients with history of proteinuria grade ≥ 2.&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP), or men who are able to father a child,&#xD;
             unwilling to use a medically acceptable method of contraception during the trial and&#xD;
             for at least three months after the end of active therapy.&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding. Persistence of clinically relevant therapy&#xD;
             related toxicity from previous chemotherapy and/or radiotherapy. This does not include&#xD;
             hemoglobin or other hematologic or laboratory criteria, as long as eligibility&#xD;
             criteria are met&#xD;
&#xD;
          -  Other malignancies within the past 5 years other than non-melanoma superficial skin&#xD;
             cancer or carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Concurrent medical conditions or injury which may increase the risk of toxicity,&#xD;
             including ongoing or active infection, history of significant bleeding disorder&#xD;
             unrelated to cancer (congenital bleeding disorders, acquired bleeding disorders within&#xD;
             one year), history of HIV-positive, or active or chronic hepatitis C and/or B&#xD;
             infection.&#xD;
&#xD;
          -  Known or suspected active drug or alcohol abuse.&#xD;
&#xD;
          -  Gastrointestinal disorders or abnormalities that would interfere with absorption of&#xD;
             the study drug. Patients who are unable to orally swallow the study medication.&#xD;
&#xD;
          -  Known hypersensitivity to trial drug.&#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>Yelena Janjigian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memoral Sloan Kettering Cancer Center</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center @ Suffolk</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center 1275 York Avenue</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering at Mercy Medical Center</name>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>December 30, 2020</results_first_submitted>
  <results_first_submitted_qc>December 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 25, 2021</results_first_posted>
  <last_update_submitted>December 30, 2020</last_update_submitted>
  <last_update_submitted_qc>December 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nintedanib</keyword>
  <keyword>14-094</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nintedanib</mesh_term>
  </intervention_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>December 27, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02234596/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nintedanib</title>
          <description>Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant not treated</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>Nintedanib</title>
          <description>Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" lower_limit="34" upper_limit="75"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </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="3"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </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>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>6-month Progression-free Survival (PFS)</title>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nintedanib</title>
            <description>Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>6-month Progression-free Survival (PFS)</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="1.6" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate</title>
        <description>defined as both complete response (CR) and partial response (PR), as measured by RECIST response criteria.</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nintedanib</title>
            <description>Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate</title>
          <description>defined as both complete response (CR) and partial response (PR), as measured by RECIST response criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stable Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Progressive Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Evaluated for Toxicities</title>
        <description>The severity of adverse event should be classified and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nintedanib</title>
            <description>Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Evaluated for Toxicities</title>
          <description>The severity of adverse event should be classified and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nintedanib</title>
          <description>Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="26" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Heart Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death NOS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin &amp; subcutaneous tissue disorders, Other, spec</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>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="32" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </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" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Yelena Janjigian,</name_or_title>
      <organization>Memorial Sloan Kettering Cancer Center</organization>
      <phone>646-888-4186</phone>
      <email>janjigiy@mskcc.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/NCT02234596
org study id: 14-094
nct id: NCT02234596
lead sponsor: 
This is a phase II study of Nintedanib in patients with metastatic or recurrent
      esophagogastric cancer. The goal of the study is to evaluate the efficacy of Nintedanib, an
      orally available triple kinase inhibitor targeting the receptors of the vascular endothelial
      growth factor (VEGF), platelet derived growth factor (PDGF), and fibroblast growth factor
      (FGF) receptor pathways.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 6-month Progression-free Survival (PFS)
time frame: 6 months
measure: Objective Response Rate
time frame: 3 years
description: defined as both complete response (CR) and partial response (PR), as measured by RECIST response criteria.
measure: Participants Evaluated for Toxicities
time frame: 3 years
description: The severity of adverse event should be classified and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
arm group label: Nintedanib
arm group type: Experimental
intervention type: Drug
intervention name: Nintedanib
description: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
arm group label: Nintedanib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yelena Janjigian, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Nintedanib
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 