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Brief Title: A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II)
Official Title: A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor
Study ID: NCT01482715
Brief Summary: Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors. Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or somatic). Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).
Detailed Description: Rucaparib (CO-338; formerly known as PF 01367338 and AG 14699) is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination \[HR\] DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with BRCA1 or BRCA2 mutations. For this study, it is anticipated that rucaparib will promote cell death in the BRCA-deficient tumor cells of ovarian cancer patients with evidence of a germline mutation, thereby limiting tumor progression and providing therapeutic benefit.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
UCSF, San Francisco, California, United States
Sarah Cannon Research Institute, Sarasota, Florida, United States
Dana-Farber Cancer Institute (Part 3 only), Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Hospital Vall d'Hebron, Barcelona, , Spain
Guy's and St Thomas NHS Foundation Trust, London, England, United Kingdom
Royal Marsden NHS Foundation Trust, London, England, United Kingdom
Imperial College Healthcare, London, England, United Kingdom
Newcastle University, Newcastle Upon Tyne, England, United Kingdom
Institution of Cancer Science, University of Glasgow Wolfson Wohl Cancer Research, Glasgow, Scotland, United Kingdom
University College London Cancer Institute, London, , United Kingdom