A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With a Solid Tumor or With gBRCA Mutation Ovarian Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Grade 3 or 4 adverse events and clinical lab abnormalities defined as DLTs (Part 1)
Cycle 1 Days 1, 8, 15 and 22
Yes
United States: Food and Drug Administration
CO-338-010
NCT01482715
November 2011
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Sarah Cannon Research Institute | Sarasota, Florida 34232 |