Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer

NCT ID: NCT01661868

Last Updated: 2012-08-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-08-31

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.

Conditions

Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Keywords

BRCA1 mutation; BRCA2 mutation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PARP Inhibitor Naive

Patients with no prior PARP inhibitor treatment

Group Type: ACTIVE_COMPARATOR

Olaparib

Intervention Type: DRUG

Tablet formulation will be used.

Prior PARP Inhibitor

Patients previously treated with a PARP inhibitor other than olaparib

Group Type: ACTIVE_COMPARATOR

Olaparib

Intervention Type: DRUG

Tablet formulation will be used.

Interventions

Olaparib

Tablet formulation will be used.

Intervention Type: DRUG

Other Intervention Names

AZD2281

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ursula A. Matulonis, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ursula A Matulonis, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-170

Identifier Type: -

Identifier Source: org_study_id