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
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
Maryland Oncology Hematology
🇺🇸Annapolis, Maryland, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
HCA Midwest Health Kansas City Research
🇺🇸Kansas City, Missouri, United States
Center of Hope
🇺🇸Reno, Nevada, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Optimum Clinical Research Group- Women's Oncology
🇺🇸Albuquerque, New Mexico, United States
Westchester Medical Center
🇺🇸Hawthorne, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Trihealth Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Ohio State University James Cancer Hospital
🇺🇸Columbus, Ohio, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute
🇺🇸Eugene, Oregon, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Northwest Cancer Specialists
🇺🇸Portland, Oregon, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Ascension St. Thomas Midtown Hospital
🇺🇸Nashville, Tennessee, United States
Texas Oncology Austin
🇺🇸Austin, Texas, United States
Texas Oncology Fort Worth Cancer Center
🇺🇸Fort Worth, Texas, United States
Texas Oncology Gulf Coast
🇺🇸Houston, Texas, United States
Texas Oncology San Antonio
🇺🇸San Antonio, Texas, United States
VCU Health System
🇺🇸Richmond, Virginia, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Virginia Cancer Specialists
🇺🇸Warrenton, Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Northern Cancer Institute
🇦🇺St Leonards, New South Wales, Australia
Icon Cancer Centre- Chermside
🇦🇺Brisbane, Queensland, Australia
Mater Cancer Care Centre, Mater Misericordiae Limited
🇦🇺Brisbane, Queensland, Australia
Burnside War Memorial Hospital
🇦🇺Toorak Gardens, South Australia, Australia
Cabrini Hospital Malvern
🇦🇺Malvern, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Chu de Quebec-Universite
🇨🇦Quebec City, Quebec, Canada
Rustavi Clinic
🇬🇪Rustavi, Kvemo Kartli, Georgia
LTD High Technology Hospital Medcenter
🇬🇪Batumi, Republic Of Adjara, Georgia
Acad. Fridon Todua Medical Center
🇬🇪Tbilisi, Georgia
LTD Innova Medical Center
🇬🇪Tbilisi, Georgia
LTD TIM-Tbilisi Innova of Medicine
🇬🇪Tbilisi, Georgia