<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/NCT01690598</url>
  </required_header>
  <id_info>
    <org_study_id>VeTo</org_study_id>
    <nct_id>NCT01690598</nct_id>
  </id_info>
  <brief_title>Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status</brief_title>
  <official_title>Veliparib (ABT888) and Topotecan (Hycamtin®) for Patients With Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer With Negative or Unknown BRCA Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vejle Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vejle Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of combined topotecan and veliparib&#xD;
      (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown&#xD;
      BRCA mutation status.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1/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>Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status</measure>
    <time_frame>Every three months, up to 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival of ovarian cancer patients treated with topotecan and veliparib</measure>
    <time_frame>Every three months up to three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival of ovarian cancer patients treated with topotecan and veliparib</measure>
    <time_frame>Every three months, up to three years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Veliparib and Topotecan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Veliparib</intervention_name>
    <description>Veliparib (tablet) twice daily on days 1-3, 7-9, and 14-16 in a 28 days cycle. In phase I the starting dose is 30 mg x 2.</description>
    <arm_group_label>Veliparib and Topotecan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topotecan</intervention_name>
    <description>2 mg/m² iv over 30 minutes on days 2, 8, and 15 in cycles of 28 days. Topotecan is dosed at a maximum body surface area of 2 m².</description>
    <arm_group_label>Veliparib and Topotecan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.&#xD;
&#xD;
          2. Verified progression by either RECIST criteria and/or GCIG CA125 criteria after&#xD;
             previous first line chemotherapy or progression after later lines of cytotoxic&#xD;
             treatment.&#xD;
&#xD;
          3. Platinum resistance or partially platinum sensitive disease&#xD;
&#xD;
               -  Relapsed within six months of prior first line/later lines of platinum-based&#xD;
                  therapy or&#xD;
&#xD;
               -  Relapsed within six-twelve months of prior first line/later lines of&#xD;
                  platinum-based therapy&#xD;
&#xD;
          4. Age ≥ 18 years.&#xD;
&#xD;
          5. Performance status 0-2.&#xD;
&#xD;
          6. Measurable disease by RECIST 1.1 or CA125 GCIG criteria&#xD;
&#xD;
          7. Adequate bone marrow function, liver function, renal function and coagulation&#xD;
             parameters (within 7 days prior to enrollment):&#xD;
&#xD;
               -  WBC ≥ 3.0 x 10^9/l or neutrophils (ANC) ≥ 1.5 x 10^9/l&#xD;
&#xD;
               -  Platelet count ≥ 100 x 109/l&#xD;
&#xD;
               -  Hemoglobin ≥ 9.7 g/dl (6 mmol/L)&#xD;
&#xD;
               -  Serum bilirubin ≤ 1.5 x ULN&#xD;
&#xD;
               -  Serum transaminases ≤ 2.5 x ULN&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 x ULN&#xD;
&#xD;
          8. Written informed consent.&#xD;
&#xD;
          9. Tissue available for BRCAness analysis/BRCA mutation analysis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior treatment with a PARP inhibitor.&#xD;
&#xD;
          2. Patients with BRCA1/2 germline mutation.&#xD;
&#xD;
          3. Platinum-refractory disease (disease that progressed or was stable during prior&#xD;
             platinum therapy)&#xD;
&#xD;
          4. Patients who have received (or are planning to receive) treatment with any other&#xD;
             investigational agent, or who have participated in another clinical trial within 28&#xD;
             days prior to entering this trial.&#xD;
&#xD;
          5. Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening&#xD;
             is mandatory.&#xD;
&#xD;
          6. Fertile patients not willing to use acceptable and safe methods of contraception&#xD;
             during and for 6 months after treatment&#xD;
&#xD;
          7. Other present or previous malignancy except curatively treated cervical cancer stage&#xD;
             I, non-melanotic skin cancer or other cancer with minimal risk of relapse. Previous&#xD;
             breast cancer is allowed, if disease free follow-up at least five years prior to&#xD;
             enrollment.&#xD;
&#xD;
          8. CNS metastasis.&#xD;
&#xD;
          9. History of any chronic medical or psychiatric condition or laboratory abnormality,&#xD;
             which is not medically controlled or in the opinion of the Investigator may increase&#xD;
             the risks associated with study drug administration (e.g. diabetes, cardiac diseases,&#xD;
             hypertension, renal or liver disease).&#xD;
&#xD;
         10. Allergy to the ingredients of the study medication.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders Jakobsen, MD, DMSc</last_name>
    <role>Study Chair</role>
    <affiliation>Vejle Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanne Kanstrup, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vejle Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oncology, Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <zip>DK-7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>June 9, 2015</last_update_submitted>
  <last_update_submitted_qc>June 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epithelial ovarian cancer</keyword>
  <keyword>BRCA mutation</keyword>
  <keyword>Platinum resistant</keyword>
  <keyword>Platinum sensitive</keyword>
  <keyword>Relapsed ovarian cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Topotecan</mesh_term>
    <mesh_term>Veliparib</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01690598
org study id: VeTo
nct id: NCT01690598
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to investigate the effect of combined topotecan and veliparib
      (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown
      BRCA mutation status.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib
time frame: 1 month
measure: Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status
time frame: Every three months, up to 3 years
measure: Progression free survival of ovarian cancer patients treated with topotecan and veliparib
time frame: Every three months up to three years
measure: Overall survival of ovarian cancer patients treated with topotecan and veliparib
time frame: Every three months, up to three years
arm group label: Veliparib and Topotecan
arm group type: Experimental
intervention type: Drug
intervention name: Veliparib
description: Veliparib (tablet) twice daily on days 1-3, 7-9, and 14-16 in a 28 days cycle. In phase I the starting dose is 30 mg x 2.
arm group label: Veliparib and Topotecan
intervention type: Drug
intervention name: Topotecan
description: 2 mg/m² iv over 30 minutes on days 2, 8, and 15 in cycles of 28 days. Topotecan is dosed at a maximum body surface area of 2 m².
arm group label: Veliparib and Topotecan
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anders Jakobsen, MD, DMSc
role: Study Chair
affiliation: Vejle Hospital
last name: Hanne Kanstrup, MD
role: Principal Investigator
affiliation: Vejle Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Topotecan
mesh term: Veliparib