Skip to main content
Eligibility
for males ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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

Official Title

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

Keywords

Metastatic Castration-Resistant Prostate Cancer Metastatic Castration-Resistant Prostate Cancer (mCRPC) Phase 1b Prostate Cancer Pharmacokinetics (PK) ZEN003694 ZEN-3694 Metastatic Castrate-Resistant Prostate Cancer BET inhibitor (BETi) Bromodomain Pharmacodynamics (PD) Enzalutamide XTANDI MDV3100 Epigenetics

Eligibility

You can join if…

Open to males ages 18 years and up

  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 only: Enzalutamide-naïve patients following prior progression on abiraterone by PCWG2 criteria and within 12 weeks of discontinuing abiraterone
  7. 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.
  8. 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

You CAN'T join if...

  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

  • University of California Los Angeles Medical Center accepting new patients
    Los Angeles, California, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zenith Epigenetics
ID
NCT02711956
Phase
Phase 1
Lead Scientist
Rahul Aggarwal
Study Type
Interventional
Last Updated
February 2017
I'm interested in this study!