A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma
- Registration Number
- NCT04814108
- Lead Sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
- Brief Summary
This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).
- Detailed Description
This is a Phase 2 open-label, multicenter study to evaluate the clinical activity and safety of ZN-c3 (also known as azenosertib; KP-2638) in adult women with recurrent or persistent uterine serous carcinoma (USC).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ZN-c3 Single Agent ZN-c3 ZN-c3 (azenosertib) taken orally with food
- Primary Outcome Measures
Name Time Method Frequency and severity of TEAEs and incidence of dose modifications 2 years To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.
Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR 2 years To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC
- Secondary Outcome Measures
Name Time Method Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. 2 years To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. 2 years To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. 2 years To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. 2 years To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. 2 years To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Trial Locations
- Locations (52)
Revive Clinical Research
🇺🇸Sterling, Michigan, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Alaska Women's Cancer Care
🇺🇸Anchorage, Alaska, United States
Honor Health
🇺🇸Phoenix, Arizona, United States
Arizona Oncology Associates Wilmot HOPE
🇺🇸Tucson, Arizona, United States
University of California Irvine Medical Center
🇺🇸Orange, California, United States
University of California San Francisco at Mission Bay
🇺🇸San Francisco, California, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Scroll for more (42 remaining)Revive Clinical Research🇺🇸Sterling, Michigan, United States