<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/NCT01661868</url>
  </required_header>
  <id_info>
    <org_study_id>11-170</org_study_id>
    <nct_id>NCT01661868</nct_id>
  </id_info>
  <brief_title>Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer</brief_title>
  <official_title>Phase II Study of Single Agent Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer With No Prior PARP Exposure or Prior PARP Inhibitor Exposure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is a way of gaining new knowledge about a drug called olaparib in women&#xD;
      who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1)&#xD;
      or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the&#xD;
      exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from&#xD;
      repairing their DNA. In this research study, we are looking to see how well the drug olaparib&#xD;
      works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well&#xD;
      as those who have received a prior PARP inhibitor and whose cancer has re-grown after&#xD;
      receiving that PARP inhibitor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Olaparib tablets will be taken twice daily, orally, in treatment cycles lasting 4 weeks.&#xD;
&#xD;
      On days 1, 8, 12 and 22 of the first 2 cycles and day 1 of all other cycles, subjects will&#xD;
      have a physical exam, be asked questions about their general health, and specific questions&#xD;
      about any problems they might be having and any medications they are taking.&#xD;
&#xD;
      Tumor will be assess by either CT or MRI scan every 2 cycles (every 2 months). Tumor biopsies&#xD;
      will be optional in this study. Only participants that have received a PARP inhibitor in the&#xD;
      past will be asked to have a biopsy of their tumor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Drug not available.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response Rates</measure>
    <time_frame>1 year</time_frame>
    <description>To determine the RECIST 1.1. response rates of the oral PARP inhibitor olaparib based on prior exposure of a PARP inhibitor; patients who have received and subsequently have had disease progression with a prior PARP inhibitor versus no prior exposure to a PARP inhibitor in patients with germline BRCA mutations who have recurrent ovarian, fallopian tube or peritoneal cancer who have measurable cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toxicity</measure>
    <time_frame>1 year</time_frame>
    <description>Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Assess progression free survival (PFS) and 6 month PFS rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>1 year</time_frame>
    <description>Assess CA125 response rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Peritoneal Cancer</condition>
  <condition>Fallopian Tube Cancer</condition>
  <arm_group>
    <arm_group_label>PARP Inhibitor Naive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with no prior PARP inhibitor treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prior PARP Inhibitor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients previously treated with a PARP inhibitor other than olaparib</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>Tablet formulation will be used.</description>
    <arm_group_label>PARP Inhibitor Naive</arm_group_label>
    <arm_group_label>Prior PARP Inhibitor</arm_group_label>
    <other_name>AZD2281</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed ovarian, peritoneal or fallopian tube cancer that has&#xD;
             recurred following a platinum-based regimen used at initial diagnosis&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
          -  Estimated life expectancy greater than 16 weeks&#xD;
&#xD;
          -  Normal organ and marrow function&#xD;
&#xD;
          -  Evidence of non-childbearing status for women of childbearing potential&#xD;
&#xD;
          -  Able to swallow oral medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Prior PARP inhibitor use for another cancer such as breast cancer&#xD;
&#xD;
          -  Receiving any other study agents or any other anti-cancer treatment&#xD;
&#xD;
          -  Known brain metastases&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to olaparib&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  History of a different malignancy unless disease-free for at least 5 years&#xD;
&#xD;
          -  Currently experiencing seizures or currently being treated with any anti-epileptic for&#xD;
             seizures&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) positive on combination antiretroviral therapy&#xD;
&#xD;
          -  Presence of gastrointestinal disorders that, in the investigator's opinion, are likely&#xD;
             to interfere with the absorption of olaparib, or with the patient's ability to take&#xD;
             regular oral 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>Ursula A Matulonis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>October 24, 2011</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 18, 2012</last_update_submitted>
  <last_update_submitted_qc>August 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Ursula A. Matulonis, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>BRCA1 mutation</keyword>
  <keyword>BRCA2 mutation</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>
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olaparib</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/NCT01661868
org study id: 11-170
nct id: NCT01661868
lead sponsor: 
has dmc: Yes
This research study is a way of gaining new knowledge about a drug called olaparib in women
      who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1)
      or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the
      exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from
      repairing their DNA. In this research study, we are looking to see how well the drug olaparib
      works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well
      as those who have received a prior PARP inhibitor and whose cancer has re-grown after
      receiving that PARP inhibitor.
Olaparib tablets will be taken twice daily, orally, in treatment cycles lasting 4 weeks.

      On days 1, 8, 12 and 22 of the first 2 cycles and day 1 of all other cycles, subjects will
      have a physical exam, be asked questions about their general health, and specific questions
      about any problems they might be having and any medications they are taking.

      Tumor will be assess by either CT or MRI scan every 2 cycles (every 2 months). Tumor biopsies
      will be optional in this study. Only participants that have received a PARP inhibitor in the
      past will be asked to have a biopsy of their tumor.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response Rates
time frame: 1 year
description: To determine the RECIST 1.1. response rates of the oral PARP inhibitor olaparib based on prior exposure of a PARP inhibitor; patients who have received and subsequently have had disease progression with a prior PARP inhibitor versus no prior exposure to a PARP inhibitor in patients with germline BRCA mutations who have recurrent ovarian, fallopian tube or peritoneal cancer who have measurable cancer.
measure: Toxicity
time frame: 1 year
description: Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)
measure: Progression free survival
time frame: 1 year
description: Assess progression free survival (PFS) and 6 month PFS rate
measure: Response Rate
time frame: 1 year
description: Assess CA125 response rate
arm group label: PARP Inhibitor Naive
arm group type: Active Comparator
description: Patients with no prior PARP inhibitor treatment
arm group label: Prior PARP Inhibitor
arm group type: Active Comparator
description: Patients previously treated with a PARP inhibitor other than olaparib
intervention type: Drug
intervention name: Olaparib
description: Tablet formulation will be used.
arm group label: PARP Inhibitor Naive
arm group label: Prior PARP Inhibitor
other name: AZD2281
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ursula A Matulonis, MD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Ursula A. Matulonis, MD
investigator title: Principal Investigator
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Fallopian Tube Neoplasms
mesh term: Olaparib