Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

In brief

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.

Key facts

Study ID

NCT01661868

Run by

Dana-Farber Cancer Institute

People needed

0

Starts

2012-08-01

Expected to finish

2012-08-01

Last updated by the study team

2012-08-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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