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


Active: Yes
Cancer Type: Gynecologic Cancers
Primary Peritoneal Cancer
Unknown Primary
NCT ID: NCT05128825
Trial Phases: Phase II Protocol IDs: ZN-c3-005 (primary)
NCI-2022-03875
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
NCI Full Details: http://clinicaltrials.gov/show/NCT05128825

Summary

This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib
(ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube,
or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose
tumors are Cyclin E1 positive as determined by central review using the Sponsor's
investigational clinical trial assay.

Objectives

A Phase 2 study to evaluate the efficacy and safety of azenossertib (ZN-c3) in subjects
with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal
Cancer. Azenosertib is a selective and orally bioavailable inhibitor of WEE1. By
inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA
damage, thereby resulting in the accumulation of DNA damage leading to mitotic
catastrophe and cancer cell death.

The study consists of two parts:

Part 1: All comers, no biomarker status required (completed enrollment)

Part 2: Cyclin E1 positive protein expression required

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.