Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Intervention / Treatment
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* Drug: Olaparib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PARP Inhibitor Naive<br>Patients with no prior PARP inhibitor treatment | Drug: Olaparib<br>* Tablet formulation will be used.<br>* Other names: AZD2281;|
| Active Comparator: Prior PARP Inhibitor<br>Patients previously treated with a PARP inhibitor other than olaparib | Drug: Olaparib<br>* Tablet formulation will be used.<br>* Other names: AZD2281;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4) | 1 year | 
| Progression free survival | Assess progression free survival (PFS) and 6 month PFS rate | 1 year | 
| Response Rate | Assess CA125 response rate | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRCA1 mutation, BRCA2 mutation