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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Ursula A Matulonis, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|