Study of Abemaciclib Combined with Olaparib in Women with Recurrent Platinum-Resistant Ovarian Cancer

What this Trial Is About

Researchers are evaluating the combination of abemaciclib and olaparib in treating women with recurrent platinum-resistant ovarian cancer, a type of ovarian cancer that initially responds to platinum-based chemotherapy but returns within six months. This phase IIb trial aims to identify the side effects and best dose of abemaciclib when given together with olaparib. The study also explores the anti-tumor activity of this combination and collects genetic and biomarker data to understand treatment responses better. Participants receive olaparib orally twice daily for 28-day cycles, with abemaciclib added from day 8 to day 28 in the first cycle and throughout subsequent cycles, continuing until disease progression or unacceptable side effects occur. The study includes procedures like blood collection and tumor biopsies. After completing treatment, participants are followed up for 30 days to monitor outcomes and safety. During the study, participants undergo regular assessments including blood tests and tumor biopsies to measure response and side effects. Researchers track the maximum tolerated dose and recommended phase 2 dose after the first 28-day cycle. They also observe overall response rates and duration of response following treatment completion. Genetic and biomarker analyses are performed on collected samples, and safety is monitored throughout participation, which may last several treatment cycles plus follow-up.

Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer