Phase 3 Study Comparing INCB123667 With Chemotherapy in Women With Platinum-Resistant Ovarian Cancer Showing Cyclin E1 Overexpression

What this Trial Is About

Researchers are evaluating INCB123667 compared to the investigators choice of chemotherapy in adults with platinum-resistant ovarian cancer characterized by cyclin E1 overexpression. This Phase 3 trial aims to assess treatment outcomes in participants who have specific tumor types and prior treatment histories. The study focuses on participants with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who meet detailed criteria for platinum resistance and prior therapies. Participants are randomly assigned to receive either INCB123667 as an oral tablet or chemotherapy selected by the investigator following protocol guidelines. The chemotherapy options are defined by the study protocol, and both treatments are given at protocol-defined doses. The trial includes two experimental treatment groups and does not use masking or blinding. Treatment continues with monitoring over a period of up to two years. Throughout the study, participants undergo regular assessments including tumor measurements by RECIST criteria, safety evaluations for adverse events, and quality of life questionnaires such as the EORTC QLQ-Core 30 and EQ-5D-5L. Researchers will monitor progression-free survival and overall survival as primary outcomes, along with response rates and treatment tolerability. The total study duration for participants may extend up to two years, with close follow-up to evaluate treatment effects and safety.

Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression