Clinical Research Directory
Browse clinical research sites, groups, and studies.
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
Sponsor: Zenith Epigenetics
Summary
This is an open-label, randomized, Phase 2b study of ZEN003694 in combination with enzalutamide vs. enzalutamide monotherapy in patients with mCRPC who have progressed on prior abiraterone by PCWG3 criteria. Disease must have progressed on only abiraterone by PCWG3 criteria prior to study entry. The patient population will be separated into two cohorts: Cohort A: Patients with poor response to prior abiraterone defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: \< 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: \< 6 months duration on abiraterone or failure to achieve PSA50 response while on abiraterone Cohort B: Patients with response to prior abiraterone, defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA \< 0.2 ng/mL, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and confirmed PSA50 response
Official title: A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2021-09-08
Completion Date
2026-06
Last Updated
2025-01-24
Healthy Volunteers
No
Interventions
ZEN003694
72 mg PO QD
Enzalutamide
160 mg PO QD
Locations (31)
California Research Institute
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Colorado Urology
Lakewood, Colorado, United States
D&H Cancer Research Center, LLC
Margate, Florida, United States
BRCR Global
Plantation, Florida, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
Messino Cancer Center
Asheville, North Carolina, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
Texas Oncology - Central South
Austin, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Anhui Provincial Hospital
Hefei, Anhui, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotang University
Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China