Phase 2 Study of Azenosertib ZN-c3 for Women With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer with Cyclin E1 Positive Tumors

What this Trial Is About

Researchers are evaluating the efficacy and safety of azenosertib ZN-c3, an oral drug that inhibits WEE1, in people with platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. This Phase 2 study includes patients whose tumors test positive for Cyclin E1 protein. The study is designed to understand how azenosertib affects cancer cell growth by allowing damaged cells to continue the cell cycle, leading to cancer cell death. The study has two parts Part 1 included all patients regardless of biomarker status and has completed enrollment. Part 2 focuses on patients with Cyclin E1 positive tumors. Participants receive azenosertib orally at doses of either 300mg or 400mg daily, following a schedule of five days on treatment followed by two days off. Several study arms explore different dosing groups within this intermittent treatment plan. Participants will be monitored for up to approximately 12 months after the last patients enrollment. The study includes regular assessments of tumor response using RECIST criteria, measurement of biomarkers like CA-125, and tracking of side effects. Researchers will measure objective response rate as the primary outcome, along with duration of response, progression-free survival, clinical benefit rate, and treatment-emergent adverse events. This comprehensive monitoring aims to understand the treatments effects and safety profile over time.

A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer