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A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 1b/2a Safety and Tolerability Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT02711956•Zenith Epigenetics

View on ClinicalTrials.gov

Summary

This is an open label, non-randomized, Phase 1b/2a, dose escalation and dose confirmation study of ZEN003694 in combination with enzalutamide in patients with mCRPC.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Males age ≥ 18 years
•2. Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ≥ 8 weeks prior to screening
•3. Serum testosterone \< 50 ng/dL determined within 4 weeks of first administration of study drug
•4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•5. Adequate laboratory parameters \[absolute neutrophil (ANC), platelets, asparate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine and coagulation parameters\] at screening
•6. Dose Escalation Cohort DE-A: Prior progression on enzalutamide or apalutamide at any time by PCWG2 criteria and receiving a stable dose of enzalutamide at the start of study treatment.
•7. Dose Escalation Cohort DE-B: Enzalutamide-naïve and apalutamide-naïve patients following prior progression on abiraterone by PCWG2 criteria and receiving a stable dose of enzalutamide at the start of study treatment.
•8. Dose Confirmation Cohort A (DC-A) only: Currently receiving enzalutamide as most recent systemic therapy for mCRPC and have experienced PSA progression by PCWG2 criteria in the absence of radiographic and/or clinical progression. Patients may or may not have experienced prior progression on abiraterone.
•9. Dose Confirmation Cohort B (DC-B) only: Enzalutamide-naïve patients following prior progression on abiraterone by PCWG2 criteria and within 12 weeks of discontinuing abiraterone.

Exclusion Criteria

•1. Any history of brain metastases or prior seizure or conditions predisposing to seizure activity
•2. Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-001)
•3. Have received prior systemic anti-cancer therapy (including abiraterone) or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
•4. Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
•5. Radiation therapy within 2 weeks of the first administration of study drug
•6. 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 study entry)
•7. Have received prior investigational anti-androgen therapy, including ARN-509
•8. Currently receiving medications known to be strong inhibitors of CYP2C8, strong inducers (except enzalutamide) or inhibitors of CYP3A4 and substrates of CYP3A4, CYP2C9 and CYP2C19 with a narrow therapeutic window. Strong inducers, inhibitors and substrates must be discontinued at least 7 days prior to the first administration of study drug.
•9. Not a candidate for enzalutamide treatment, in the opinion of the Investigator

Locations (8)

University of California Los Angeles Medical Center

Los Angeles, California, United States

University of California San Francisco Medical Center

San Francisco, California, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute

Farmington Hills, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medicine - New York Presbyterian

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Key Dates

Start Date

December 1, 2016

Primary Completion Date

November 1, 2019

Completion Date

November 1, 2019

Last Updated

November 30, 2021

Enrollment

ACTUAL participants

Conditions

Metastatic Castration-Resistant Prostate Cancer

Interventions

ZEN003694

DRUG

Enzalutamide

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer