Rucaparib Clinical Development Overview

Rucaparib is an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents.  Clovis holds global rights for rucaparib.

Ovarian Cancer

For rucaparib approved or authorized uses click here.

Rucaparib in patients with ovarian cancer study completed enrollment.

• The pivotal Phase 3 ATHENA study in first-line maintenance treatment study to evaluate rucaparib in combination with nivolumab in newly diagnosed patients with stage III/IV high-grade ovarian, fallopian tube or primary peritoneal cancer who have completed platinum-based chemotherapy. The 1000 patient study will provide data from two independent readouts: rucaparib monotherapy versus placebo (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO). This Clovis sponsored study is part of an ongoing clinical collaboration with Bristol Myers Squibb.

Prostate Cancer

Rucaparib is in clinical development for the treatment of metastatic castration-resistant prostate cancer (mCRPC) patients.

• Rucaparib is being studied in the Phase 3 TRITON3 trial for patients with BRCA mutations and ATM mutations who have progressed on AR-targeted therapy and who have not yet received chemo in the castrate-resistant setting. This trial has completed enrollment.
• The Phase 3 CASPAR study is evaluating the benefit of adding rucaparib to enzalutamide for men with mCRPC that has become resistant to testosterone-deprivation therapy.  This trial is open for enrollment and is sponsored by the Alliance for Clinical Trials in Oncology which is part of the National Cancer Institute.

Other Studies

Exploratory studies in other tumor types are also underway.