A Phase 2 Open-Label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (DENALI / ZN-c3-005 / GOG-3066)
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
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.
Description
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 prot…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 years 2. High-grade serous ovarian, fallopian tube or primary peritoneal cancer 3. Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay 4. Prior therapy: 1. Subjects must have platinum-resistant disease 2. Parts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab) 3. Part 2c: Subjects with PROC may have 1 to 4 prior lines or regimens. Prior treatment in this cohort includes a weekly t…
Interventions
- Drugazenosertib
Azenosertib (ZN-c3) will be administered orally.
Locations (91)
- Site 0170-USA Mitchell Cancer InstituteMobile, Alabama
- Site 0143 - HonorHealthPhoenix, Arizona
- Site 0102 - University of Arizona Cancer CenterTucson, Arizona
- Site 0258 - UC San Diego Moores Cancer CenterLa Jolla, California
- Site 0287 - Ridley Tree Cancer CenterSanta Barbara, California
- Site 0135 - Rocky Mountain Cancer CentersLone Tree, Colorado