Phase 2 Multicohort Study to Evaluate the Safety and Efficacy of Novel Treatment Combinations in Patients with Recurrent Ovarian Cancer (3000-02-005)
Johns Hopkins Kimmel Cancer Center in Baltimore
The main purpose of this study is to evaluate the ability of the Niraparib, TSR-042, and Bevacizumab combination to benefit patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer.
The study is intended for adult subjects with ovarian, fallopian tube or primary peritoneal cancer, that have been previously treated with chemotherapy that included platinum (a specific type of chemotherapy) and whose disease relapsed within 6 months of completing pre or post-operative chemotherapy.
Cohort A: Patients who have not been exposed to PARP Inhibitors and who have Platinum-Resistant ovarian, fallopian tube, or primary peritoneal cancer will receive treatment with TSR-042, Bevacizumab, and Niraparib. TSR-042 is administered at a dose of 500mg every 3 weeks for 4 cycles, followed by 1,000 mg every 6 weeks thereafter. Bevacizumab is administered at a dose of 15 mg/kg every 3 weeks for up to 15 months. Niraparib is administered at a dose of 200 or 300 mg per day (depending on weight). Mandatory tissue and blood samples will also be collected for analysis.
08/08/2020 05:02 AM