<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/NCT03032614</url>
  </required_header>
  <id_info>
    <org_study_id>CTMS#16-0133</org_study_id>
    <secondary_id>17-166H</secondary_id>
    <nct_id>NCT03032614</nct_id>
  </id_info>
  <brief_title>Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients</brief_title>
  <official_title>Phase II Clinical Trial on the Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients With Homologous Recombination Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase II clinical trial of the combination of carboplatin, eribulin, and Veliparib.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II, non-randomized, open-label, Clinical Trial on the Combination of&#xD;
      Carboplatin, Eribulin, and Veliparib in Patients with BRCA-related Cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 30, 2017</start_date>
  <completion_date type="Anticipated">April 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</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>Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)</measure>
    <time_frame>Approximately 1.5 years</time_frame>
    <description>Graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor response assessed using RECIST 1.1 guidelines</measure>
    <time_frame>Measured every 6 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year</time_frame>
    <description>Response will be assessed in this study via physical exam and imaging.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer Stage IV</condition>
  <condition>Ovarian Cancer</condition>
  <condition>BRCA1 Mutation</condition>
  <condition>BRCA2 Mutation</condition>
  <arm_group>
    <arm_group_label>Combination of Carboplatin, Eribulin, and Veliparib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eribulin will be administered intravenously (IV) on days 1 and 8 of each cycle at a dose of 1.1 mg/m2 over a 2-5 minute time period; on cycle day 1. Carboplatin will be administered intravenously at a dose of AUC 5 on day 1 of each cycle, over 30 min, immediately following eribulin infusion, per institutional guidelines. Veliparib will be given at 120 mg bid (two times a day), on days 2-12 for the first cycle of the safety run-in period and thereafter at 240 mg bid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin is a second generation tetravalent organic platinum compound. Similar to cisplatin, carboplatin produces predominantly interstrand DNA crosslinks as opposed to DNA-protein crosslinks. Carboplatin is cell-cycle non-specific.</description>
    <arm_group_label>Combination of Carboplatin, Eribulin, and Veliparib</arm_group_label>
    <other_name>Paraplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eribulin</intervention_name>
    <description>Eribulin Mesylate is a synthetic halichondrin analog.</description>
    <arm_group_label>Combination of Carboplatin, Eribulin, and Veliparib</arm_group_label>
    <other_name>Halaven</other_name>
    <other_name>E7389</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Veliparib</intervention_name>
    <description>Veliparib is a potent PARP inhibitor that delays the repair of DNA damage induced by chemotherapeutics.</description>
    <arm_group_label>Combination of Carboplatin, Eribulin, and Veliparib</arm_group_label>
    <other_name>ABT-888</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have archival biopsy specimens (preferably from metastatic disease)&#xD;
             available for research tests. If a suitable biopsy specimen is not available, patients&#xD;
             will be asked to undergo a research biopsy to procure tissue&#xD;
&#xD;
          -  Patients must be &gt;/= 18 years&#xD;
&#xD;
          -  Females of childbearing potential must not have had unprotected sexual intercourse&#xD;
             within 30 days prior to study entry and must agree to use a highly effective method of&#xD;
             contraception. Females who are using hormonal contraceptives must have been on a&#xD;
             stable dose of the same hormonal contraceptive product for at least 4 weeks prior to&#xD;
             dosing and must continue to use the same contraceptive during the study and for 30&#xD;
             days after study drug discontinuation&#xD;
&#xD;
          -  Patients must have an ECOG performance status 0-1&#xD;
&#xD;
          -  Patients may have had a prior diagnosis of cancer if it has been &gt; 5 years since their&#xD;
             last treatment for that cancer&#xD;
&#xD;
          -  Patients must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  Leukocytes ≥ 3,000/uL&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1,500/uL&#xD;
&#xD;
               -  Platelets ≥ 100,000/uL&#xD;
&#xD;
               -  Creatinine within normal limits or creatinine clearance ≥30&#xD;
&#xD;
          -  Patients must be able to swallow and retain oral medication&#xD;
&#xD;
          -  Patients who were receiving prior systemic therapy: Prior treatment related side&#xD;
             effects must have resolved to &lt; Grade 2 severity (except alopecia and infertility)&#xD;
&#xD;
          -  All patients must have given signed, informed consent prior to registration on study&#xD;
&#xD;
          -  Patients must have stage IV breast or stage III and IV ovarian cancer (including&#xD;
             platinum sensitive disease)&#xD;
&#xD;
          -  Patients must have BRCA1/2 deleterious mutations, PTEN deficiency, or cancer with a&#xD;
             high HRD score as assessed by Myriad's assay&#xD;
&#xD;
          -  Patients must have measurable disease per RECIST 1.1 criteria (see above for&#xD;
             definition)&#xD;
&#xD;
          -  Patients may not have received more than 3 chemotherapeutic regimens for metastatic&#xD;
             disease&#xD;
&#xD;
          -  Patients may not have received treatment with prior carboplatin, eribulin or a PARP&#xD;
             inhibitor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or lactating are not eligible&#xD;
&#xD;
          -  Patients who are undergoing concomitant radiotherapy are not eligible&#xD;
&#xD;
          -  Patients who are receiving any other investigational agents or concurrent anticancer&#xD;
             therapy are not eligible&#xD;
&#xD;
          -  Previous systemic treatment is allowed with a 21 day washout period prior to&#xD;
             registration&#xD;
&#xD;
          -  Patients who are taking any herbal (alternative) medicines are not eligible. Patients&#xD;
             must be off any such medications by the time of registration&#xD;
&#xD;
          -  Patients with known brain metastases are not eligible for participation unless the&#xD;
             following are met:&#xD;
&#xD;
               -  Brain metastases are treated (either with surgical excision, stereotactic&#xD;
                  radiosurgery or radiotherapy and have been stable for at least 4 weeks (MRI&#xD;
                  documented)&#xD;
&#xD;
               -  Patient is asymptomatic and has discontinued corticosteroids if taken for that&#xD;
                  purpose&#xD;
&#xD;
          -  Patients with any of the following conditions or complications are NOT eligible for&#xD;
             participation:&#xD;
&#xD;
               -  GI tract disease resulting in an inability to take oral medication&#xD;
&#xD;
               -  Malabsorption syndrome&#xD;
&#xD;
               -  Require IV alimentation&#xD;
&#xD;
               -  History of prior surgical procedures affecting absorption&#xD;
&#xD;
               -  Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).&#xD;
&#xD;
               -  Hypersensitivity of any of the components of Veliparib, carboplatin, eribulin&#xD;
&#xD;
               -  History of significant neurological (no neuropathy &gt; Grade 2) or psychiatric&#xD;
                  disorders.&#xD;
&#xD;
               -  Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic&#xD;
                  hepatitis).&#xD;
&#xD;
               -  Significant non-neoplastic renal disease.&#xD;
&#xD;
               -  Immunocompromised subjects, including subjects known to be infected with human&#xD;
                  immunodeficiency virus (HIV).&#xD;
&#xD;
               -  Uncontrolled endocrine diseases (e.g., diabetes mellitus, hypothyroidism or&#xD;
                  hyperthyroidism, adrenal disorder) i.e., requiring relevant changes in medication&#xD;
                  within the last month or hospital admission within the last three months&#xD;
&#xD;
               -  Active infection requiring systemic therapy.&#xD;
&#xD;
               -  Significant cardiovascular impairment: history of congestive heart failure&#xD;
                  greater than New York Heart Association (NYHA) Class II, uncontrolled arterial&#xD;
                  hypertension, unstable angina, myocardial infarction or stroke within 6 months of&#xD;
                  the first dose of study drug; or cardiac arrhythmia requiring medical treatment.&#xD;
&#xD;
               -  Prolongation of QTc interval to &gt; 480 msec when electrolytes balance is normal.&#xD;
&#xD;
               -  Major surgery within 4 weeks prior to the first dose of study drug&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patients must have breast and ovarian cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginia Kaklamani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Health San Antonio</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
    <investigator_full_name>Virginia G. Kaklamani</investigator_full_name>
    <investigator_title>Clinical Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Veliparib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03032614
org study id: CTMS#16-0133
secondary id: 17-166H
nct id: NCT03032614
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a phase II clinical trial of the combination of carboplatin, eribulin, and Veliparib.
This is a Phase II, non-randomized, open-label, Clinical Trial on the Combination of
      Carboplatin, Eribulin, and Veliparib in Patients with BRCA-related Cancers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)
time frame: Approximately 1.5 years
description: Graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)
measure: Tumor response assessed using RECIST 1.1 guidelines
time frame: Measured every 6 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year
description: Response will be assessed in this study via physical exam and imaging.
arm group label: Combination of Carboplatin, Eribulin, and Veliparib
arm group type: Experimental
description: Eribulin will be administered intravenously (IV) on days 1 and 8 of each cycle at a dose of 1.1 mg/m2 over a 2-5 minute time period; on cycle day 1. Carboplatin will be administered intravenously at a dose of AUC 5 on day 1 of each cycle, over 30 min, immediately following eribulin infusion, per institutional guidelines. Veliparib will be given at 120 mg bid (two times a day), on days 2-12 for the first cycle of the safety run-in period and thereafter at 240 mg bid.
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin is a second generation tetravalent organic platinum compound. Similar to cisplatin, carboplatin produces predominantly interstrand DNA crosslinks as opposed to DNA-protein crosslinks. Carboplatin is cell-cycle non-specific.
arm group label: Combination of Carboplatin, Eribulin, and Veliparib
other name: Paraplatin
intervention type: Drug
intervention name: Eribulin
description: Eribulin Mesylate is a synthetic halichondrin analog.
arm group label: Combination of Carboplatin, Eribulin, and Veliparib
other name: Halaven
other name: E7389
intervention type: Drug
intervention name: Veliparib
description: Veliparib is a potent PARP inhibitor that delays the repair of DNA damage induced by chemotherapeutics.
arm group label: Combination of Carboplatin, Eribulin, and Veliparib
other name: ABT-888
criteria: 
gender: Female
gender based: Yes
gender description: Patients must have breast and ovarian cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Virginia Kaklamani, MD
role: Principal Investigator
affiliation: UT Health San Antonio
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center at San Antonio
investigator full name: Virginia G. Kaklamani
investigator title: Clinical Investigator
mesh term: Carboplatin
mesh term: Veliparib
sharing ipd: Undecided