A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02705469 |
Recruitment Status :
Completed
First Posted : March 10, 2016
Last Update Posted : November 20, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Castration-Resistant Prostate Cancer | Drug: ZEN003694 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 44 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Safety and Tolerability Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer |
Actual Study Start Date : | May 2016 |
Actual Primary Completion Date : | October 2017 |
Actual Study Completion Date : | October 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation and Dose Confirmation - ZEN003694 Single Agent
ZEN003694 will be administered orally as a single agent once daily in 28-day cycles, enrolling mCRPC patients.
|
Drug: ZEN003694 |
- For dose escalation only: Incidence of dose-limiting toxicities (DLT) [ Time Frame: Cycle 1 (Day 1 thru Day 28) ]A DLT is a treatment-related, clinically significant adverse event or laboratory abnormality occurring during the first cycle of treatment (Day 1 thru Day 28).
- For dose escalation and dose confirmation: Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) [ Time Frame: Up to 24 months ]
- Measure the pharmacokinetic (PK) parameter: AUC of ZEN003694 [ Time Frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose ]AUC is defined as the area under the curve (plasma concentration of drug over time).
- Measure the PK parameter: Cmax of ZEN003694 [ Time Frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose ]Cmax is defined as maximum or peak plasma concentration of drug.
- Measure the PK parameter: Cmin of ZEN003694 [ Time Frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose ]Cmin is defined as minimum or trough plasma concentration of drug.
- Measure the PK parameter: Tmax of ZEN003694 [ Time Frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose ]Tmax is defined as the time from dosing to the maximum plasma concentration.
- Measure the PK parameter: t1/2 of ZEN003694 [ Time Frame: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose ]t/12 is defined as the half-life of drug.
- Evaluate prostate-specific antigen (PSA) response rate by PCWG2 criteria [ Time Frame: From screening up to 24 months ]
- Evaluate radiographic response rate by PCWG2 criteria [ Time Frame: From screening up to 24 months ]
- Evaluate median progression-free survival by PCWG2 criteria [ Time Frame: From screening up to 24 months ]
- Evaluate circulating tumor cell (CTC) response rate during dose confirmation phase only [ Time Frame: From screening up to 12 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males age ≥ 18 years
- Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ≥ 8 weeks prior to screening
- Serum testosterone < 50 ng/dL determined within 4 weeks of first administration of study drug
- Prior progression on one or more androgen-receptor/androgen-synthesis inhibitor therapies (e.g. abiraterone, enzalutamide, apalutamide, TAK-700 and/or galeterone) by Prostate Cancer Working Group 2 (PCWG2) criteria. Prior progression on bicalutamide/nilutamide/flutamide/ketoconazole alone is not allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate laboratory parameters [absolute neutrophil (ANC), platelets, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine and coagulation parameters] at screening
Exclusion Criteria:
- Any history of brain metastases or prior seizure or conditions predisposing to seizure activity
- Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-002)
- Have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
- 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 first administration of study drug
- 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)
- Currently receiving medications known to be strong inducers or inhibitors of CYP3A4 with a narrow therapeutic window. Strong inducers and inhibitors of CYP3A4 with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705469
United States, California | |
University of California Los Angeles Medical Center | |
Los Angeles, California, United States | |
University of California San Francisco Medical Center | |
San Francisco, California, United States | |
United States, Michigan | |
Karmanos Cancer Institute | |
Detroit, Michigan, United States | |
Karmanos Cancer Institute | |
Farmington Hills, Michigan, United States | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States | |
United States, Virginia | |
Virginia Oncology Associates | |
Hampton, Virginia, United States | |
Virginia Oncology Associates | |
Norfolk, Virginia, United States |
Responsible Party: | Zenith Epigenetics |
ClinicalTrials.gov Identifier: | NCT02705469 |
Other Study ID Numbers: |
ZEN003694-001 |
First Posted: | March 10, 2016 Key Record Dates |
Last Update Posted: | November 20, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
ZEN003694 ZEN-3694 Metastatic Castration-Resistant Prostate Cancer (mCRPC) Phase 1 Prostate Cancer Pharmacokinetics (PK) |
Metastatic Castrate-Resistant Prostate Cancer BET inhibitor (BETi) Bromodomain Pharmacodynamics (PD) Epigenetics |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |