Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01661868

Collaborator

(none)

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer	Drug: Olaparib	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PARP Inhibitor Naive Patients with no prior PARP inhibitor treatment	Drug: Olaparib Tablet formulation will be used. Other Names: AZD2281
Active Comparator: Prior PARP Inhibitor Patients previously treated with a PARP inhibitor other than olaparib	Drug: Olaparib Tablet formulation will be used. Other Names: AZD2281

Arm

Intervention/Treatment

Active Comparator: PARP Inhibitor Naive

Patients with no prior PARP inhibitor treatment

Drug: Olaparib

Tablet formulation will be used.

Other Names:

AZD2281

Active Comparator: Prior PARP Inhibitor

Patients previously treated with a PARP inhibitor other than olaparib

Drug: Olaparib

Tablet formulation will be used.

Other Names:

AZD2281

Outcome Measures

Primary Outcome Measures

Response Rates [1 year]
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 [1 year]
Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)
Progression free survival [1 year]
Assess progression free survival (PFS) and 6 month PFS rate
Response Rate [1 year]
Assess CA125 response rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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