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Recruiting NCT04986423

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

Phase II Interventional Metastatic Castration-Resistant Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZEN003694, Enzalutamide.
Who it may be relevant to
Registry conditions: Metastatic Castration-Resistant Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Overview

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

Interventions

  • Drug ZEN003694
    72 mg PO QD
  • Drug Enzalutamide
    160 mg PO QD

Primary outcome measures

  • Cohort A: Radiographic progression-free survival (rPFS) by BICR [Time frame: Randomization up to 30 months]
Secondary outcome measures (12)
  • Cohorts A + B: Radiographic progression-free survival (rPFS) by BICR [Time frame: Randomization up to 30 months]
  • Cohort A: Radiographic progression-free survival (rPFS) by investigator assessment [Time frame: Randomization up to 30 months]
  • Cohort A + B: Radiographic progression-free survival (rPFS) by investigator assessment [Time frame: Randomization up to 30 months]
  • Cohort A: Progression-free survival (PFS) by investigator assessment [Time frame: Randomization up to 30 months]
  • Cohort A + B: Progression-free survival (PFS) by investigator assessment [Time frame: Randomization up to 30 months]
  • Cohort A: Overall survival (OS) [Time frame: Randomization up to 30 months]
  • Cohort A + B: Overall survival (OS) [Time frame: Randomization up to 30 months]
  • Cohort A: PSA50 response rate [Time frame: Randomization up to 30 months]
  • Cohort A + B: PSA50 response rate [Time frame: Randomization up to 30 months]
  • Cohort A: Assess efficacy endpoints for patients enrolled in the USA [Time frame: Randomization up to 30 months]
  • Cohort A + B: Assess efficacy endpoints for patients enrolled in the USA [Time frame: Randomization up to 30 months]
  • Objective response rate (ORR) [Time frame: Randomization up to 30 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 16 centers
  • California Research Institute — Los Angeles
  • University of California, San Francisco — San Francisco
  • Innovative Clinical Research Institute — Whittier
  • Colorado Urology — Lakewood
  • D&H Cancer Research Center, LLC — Margate
  • BRCR Global — Plantation
  • Hematology Oncology Clinic — Baton Rouge
  • Maryland Oncology Hematology, P.A. — Columbia
  • … and 8 more centers
China · 15 centers
  • Anhui Provincial Hospital — Hefei
  • Chongqing Cancer Hospital — Chongqing
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • Henan Cancer Hospital — Zhengzhou
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology — Wuhan
  • Hubei Cancer Hospital — Wuhan
  • Hunan Cancer Hospital — Changsha
  • Nanjing Drum Tower Hospital — Nanjing
  • … and 7 more centers

Identifiers

NCT: NCT04986423 · ZEN003694-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗