Back to resultsOlaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer
Primary Purpose
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Olaparib
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring BRCA1 mutation, BRCA2 mutation
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed ovarian, peritoneal or fallopian tube cancer that has recurred following a platinum-based regimen used at initial diagnosis
- Measurable disease
- Estimated life expectancy greater than 16 weeks
- Normal organ and marrow function
- Evidence of non-childbearing status for women of childbearing potential
- Able to swallow oral medication
Exclusion Criteria:
- Pregnant or breastfeeding
- Prior PARP inhibitor use for another cancer such as breast cancer
- Receiving any other study agents or any other anti-cancer treatment
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- History of a different malignancy unless disease-free for at least 5 years
- Currently experiencing seizures or currently being treated with any anti-epileptic for seizures
- Human immunodeficiency virus (HIV) positive on combination antiretroviral therapy
- Presence of gastrointestinal disorders that, in the investigator's opinion, are likely to interfere with the absorption of olaparib, or with the patient's ability to take regular oral medication
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PARP Inhibitor Naive
Prior PARP Inhibitor
Arm Description
Patients with no prior PARP inhibitor treatment
Patients previously treated with a PARP inhibitor other than olaparib
Outcomes
Primary Outcome Measures
Response Rates
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.
Secondary Outcome Measures
Toxicity
Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)
Progression free survival
Assess progression free survival (PFS) and 6 month PFS rate
Response Rate
Assess CA125 response rate
Full Information
NCT ID
NCT01661868
First Posted
October 24, 2011
Last Updated
August 18, 2012
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01661868
Brief Title
Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Drug not available.
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Keywords
BRCA1 mutation, BRCA2 mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PARP Inhibitor Naive
Arm Type
Active Comparator
Arm Description
Patients with no prior PARP inhibitor treatment
Arm Title
Prior PARP Inhibitor
Arm Type
Active Comparator
Arm Description
Patients previously treated with a PARP inhibitor other than olaparib
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
AZD2281
Intervention Description
Tablet formulation will be used.
Primary Outcome Measure Information:
Title
Response Rates
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Toxicity
Description
Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)
Time Frame
1 year
Title
Progression free survival
Description
Assess progression free survival (PFS) and 6 month PFS rate
Time Frame
1 year
Title
Response Rate
Description
Assess CA125 response rate
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed ovarian, peritoneal or fallopian tube cancer that has recurred following a platinum-based regimen used at initial diagnosis
Measurable disease
Estimated life expectancy greater than 16 weeks
Normal organ and marrow function
Evidence of non-childbearing status for women of childbearing potential
Able to swallow oral medication
Exclusion Criteria:
Pregnant or breastfeeding
Prior PARP inhibitor use for another cancer such as breast cancer
Receiving any other study agents or any other anti-cancer treatment
Known brain metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
History of a different malignancy unless disease-free for at least 5 years
Currently experiencing seizures or currently being treated with any anti-epileptic for seizures
Human immunodeficiency virus (HIV) positive on combination antiretroviral therapy
Presence of gastrointestinal disorders that, in the investigator's opinion, are likely to interfere with the absorption of olaparib, or with the patient's ability to take regular oral medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula A Matulonis, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer
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