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CompletedNCT02705469Updated Nov 20, 2017

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

A Phase 1 interventional study of ZEN003694 in Metastatic Castration-Resistant Prostate Cancer, sponsored by Zenith Epigenetics. Completed at 8 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-20.

Sponsored by Zenith Epigenetics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC.

02

Conditions studied

  • Metastatic Castration-Resistant Prostate Cancer

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Keywords

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Phase 1
  • Prostate Cancer
  • Pharmacokinetics (PK)
  • ZEN003694
  • ZEN-3694
  • Metastatic Castrate-Resistant Prostate Cancer
  • BET inhibitor (BETi)
  • Bromodomain
  • Pharmacodynamics (PD)
  • Epigenetics
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 44 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Zenith Epigenetics is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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. 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.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate laboratory parameters [absolute neutrophil (ANC), platelets, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine and coagulation parameters] at screening

Exclusion criteria

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 ZEN003694-002)
  3. 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
  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 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. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • 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

Interventions

  • DrugZEN003694
06

What researchers measure

Primary outcomes

  1. For dose escalation only: Incidence of dose-limiting toxicities (DLT)

    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).

    Time frame: Cycle 1 (Day 1 thru Day 28)

  2. 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

Secondary outcomes

  1. Measure the pharmacokinetic (PK) parameter: AUC of ZEN003694

    AUC is defined as the area under the curve (plasma concentration of drug over time).

    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

  2. Measure the PK parameter: Cmax of ZEN003694

    Cmax is defined as maximum or peak plasma concentration of drug.

    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

  3. Measure the PK parameter: Cmin of ZEN003694

    Cmin is defined as minimum or trough plasma concentration of drug.

    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

  4. Measure the PK parameter: Tmax of ZEN003694

    Tmax is defined as the time from dosing to the maximum plasma concentration.

    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

  5. Measure the PK parameter: t1/2 of ZEN003694

    t/12 is defined as the half-life of drug.

    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

  6. Evaluate prostate-specific antigen (PSA) response rate by PCWG2 criteria

    Time frame: From screening up to 24 months

  7. Evaluate radiographic response rate by PCWG2 criteria

    Time frame: From screening up to 24 months

  8. Evaluate median progression-free survival by PCWG2 criteria

    Time frame: From screening up to 24 months

  9. Evaluate circulating tumor cell (CTC) response rate during dose confirmation phase only

    Time frame: From screening up to 12 months

07

Study locations

8 sites
  • 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
  • Oregon Health & Science University
    Portland, Oregon, United States
  • Virginia Oncology Associates
    Hampton, Virginia, United States
  • Virginia Oncology Associates
    Norfolk, Virginia, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02705469
Lead sponsor
Zenith Epigenetics
Responsible party
Sponsor
First posted
Mar 10, 2016
Start date
May 2016
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Nov 20, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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