Prostate Cancer Clinical Trial

ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Males age ≥ 18 years
Metastatic, castration-resistant, histologically confirmed prostate cancer
Surgical castration or continuous medical castration for ≥ 8 weeks prior to screening; serum testosterone < 50 ng/dL confirmed within 4 weeks of first administration of study drug
Have progressed on prior abiraterone treatment by PCWG3 criteria
Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy

Cohort A only - Patient must meet definition of poor responder to abiraterone by one of the following:

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
Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: < 6 months duration on abiraterone or failure to achieve a PSA50 response

Cohort B only - Patient must meet definition of responder to abiraterone by one of the following:

Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA < 0.2 ng/mL
Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and PSA50 response
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

Any history of brain metastases, prior seizure, conditions predisposing to seizure activity
Have previously received an investigational BET inhibitor (including previous participation in this study or a study of ZEN003694)
Receipt of prior second-generation androgen receptor inhibitors (e.g. enzalutamide, apalutamide, darolutamide, proxalutamide). Receipt of first-generation AR antagonists (e.g. bicalutamide, nilutamide, flutamide) does not count towards this limit.
Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to first dose of study drug)
Have received prior systemic anti-cancer therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
Have received exogenous administration of testosterone therapy since discontinuation of abiraterone.
Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
Radiation therapy within 2 weeks of the first administration of study drug

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT04986423

Recruitment Status:

Recruiting

Sponsor:

Zenith Epigenetics

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There are 22 Locations for this study

See Locations Near You

University of California, San Francisco
San Francisco California, 94158, United States
Colorado Urology
Lakewood Colorado, 80228, United States
Hematology Oncology Clinic
Baton Rouge Louisiana, 70809, United States
University of Michigan Rogel Cancer Center
Ann Arbor Michigan, 48109, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York New York, 10065, United States
Messino Cancer Center
Asheville North Carolina, 28806, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Anhui Provincial Hospital
Hefei Anhui, 23000, China
Chongqing Cancer Hospital
Chongqing Chongqing, 40003, China
The First Affiliated Hospital of Xiamen University
Xiamen Fujian, 36100, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
Wuhan Hubei, 43003, China
Hubei Cancer Hospital
Wuhan Hubei, 43007, China
Hunan Cancer Hospital
Changsha Hunan, 41000, China
Nanjing Drum Tower Hospital
Nanjing Jiangsu, 21000, China
Liaoning Cancer Hospital
Shenyang Liaoning, 11004, China
The First Affiliated Hospital of Xi'an Jiaotang University
Xi'an Shaanxi, 71000, China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, 20003, China
Shanghai Tenth People's Hospital
Shanghai Shanghai, 20007, China
First Hospital of Shanxi Medical University
Taiyuan Shanxi, 03000, China
Sichuan Provincial People's Hospital
Chengdu Sichuan, 61007, China
Zhejiang Provincial People's Hospital
Hangzhou Zhejiang, 31001, China

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT04986423

Recruitment Status:

Recruiting

Sponsor:


Zenith Epigenetics

How clear is this clinincal trial information?

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