A Phase II Study of Rucaparib in Patients Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Protocol
13-255
Full Title
A Phase 2, Open-Label Study of Rucaparib in Patients with Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Phase
II
Disease Status
Relapsed/Refractory
Purpose

The purpose of this study is to assess the safety and effectiveness of an investigational drug called rucaparib in women with high-grade ovarian, fallopian tube, or primary peritoneal cancer that initially responded to platinum-based chemotherapy and then returned. Rucaparib is designed to kill cancer cells by blocking a protein called PARP, thereby preventing the repair of DNA or genetic damage in cancer cells.

Research has shown that some patients with cancer and a mutation in a BRCA gene may benefit from treatment with a PARP inhibitor. In addition, some patients with mutations in a gene that is similar to BRCA may also benefit from a PARP inhibitor. As part of this study, researchers will be studying biomarkers in patients’ tumor tissue and blood to look for these gene mutations and other biomarkers and to see if the kinds of biomarkers a patient has are related to how well she responds to rucaparib. Patients must therefore agree to have their biomarkers tested to participate in this study. (Note: The study is not recruiting patients with a known germline BRCA mutation at this time.)

Rucaparib is a tablet that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have high-grade ovarian, fallopian tube, or primary peritoneal cancer that initially responded to at least one prior regimen of platinum-based chemotherapy and then returned.
  • At least 2 weeks must pass since completion of prior therapy and entry into the study.
  • Patients may not have previously received a PARP inhibitor.
  • Patients must be willing to undergo a core needle biopsy and have a site of disease that can be biopsied.
  • This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Katherine M. Bell-McGuinn at 646-888-4221.

Disease(s)
Ovarian Cancer
Locations
Related Diseases