A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive High-Grade Serous or Endometrioid Epithelial Ovarian Primary Peritoneal or Fallopian Tube Cancer
Brief description of study
Patients enrolled into this study will be stratified into 3 groups based on gene mutations
identified in their tumor tissue. The purpose of this study is to evaluate patient response
to maintenance treatment with rucaparib versus placebo. Response to treatment will be
analyzed based on homologous recombination (HR) status of tumor samples.
Clinical Study Identifier: NCT01968213
Detailed Study Description
Rucaparib 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). Clinical data have shown that
ovarian cancer patients with and without evidence of a gBRCA mutation benefit from treatment
with a PARP and that maintenance treatment with a PARP inhibitor following a response to
platinum-based treatment increases PFS in patients with ovarian cancer. While patients with a
BRCA mutation derived the most benefit, patients without evidence of a BRCA mutation also
derived significant benefit.
Patients enrolled into this study will be stratified into 3 groups based on tumor HRD status.
The purpose of this study is to identify which of these groups of patients will most likely
benefit from treatment with rucaparib. It is anticipated that rucaparib will provide
therapeutic benefit and increase PFS in patients with HRD associated with a BRCA gene
mutation or other HR gene alteration.