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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Azenosertib is an investigational drug.
Frequency and severity of TEAEs
To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.
Time frame: 2 years
Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC
Time frame: 2 years
Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Time frame: 2 years
Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Time frame: 2 years
Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Time frame: 2 years
Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Time frame: 2 years
Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
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Alaska Women's Cancer Care
Anchorage, Alaska, United States
Honor Health
Phoenix, Arizona, United States
Arizona Oncology Associates Wilmot HOPE
Tucson, Arizona, United States
Banner University Medical Center Tucson
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
Northside Hospital
Atlanta, Georgia, United States
...and 46 more locations
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
Time frame: 2 years