Phase 3 Study Comparing Oral Azenosertib With Chemotherapy in Women With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Positive for Cyclin E1 Protein

What this Trial Is About

Researchers are conducting a Phase 3 randomized trial to evaluate how well azenosertib works and how safe it is compared to chemotherapy chosen by the doctor for women with platinum-resistant high-grade serous ovarian, primary peritoneal, or fallopian tube cancers that test positive for cyclin E1 protein. This cancer type relies on WEE1 for cell cycle control, and azenosertib targets this pathway to increase tumor cell damage and death. The study compares two treatment groups one receives azenosertib orally at 400 mg daily on a schedule of 5 days on and 2 days off, while the other group receives chemotherapy selected by the investigator according to protocol guidelines. The chemotherapy options include paclitaxel, gemcitabine, pegylated liposomal doxorubicin PLD, or topotecan, all given intravenously. Treatments continue as per the study plan to assess their effects. Participants will be closely monitored for up to about 24 months after the last person enrolls. Researchers will perform regular assessments including tumor measurements using RECIST criteria, quality of life questionnaires, and tracking of side effects or adverse events. The main outcome measured is progression-free survival, with additional evaluations of overall survival and response rates. Safety and quality of life changes will also be followed throughout the study.

A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression