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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, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC.

Official Title

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

Keywords

Metastatic Castration-Resistant Prostate Cancer 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

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. 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

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 ZEN003694-002)
  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.

Locations

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zenith Epigenetics
ID
NCT02705469
Phase
Phase 1
Lead Scientist
Rahul Aggarwal
Study Type
Interventional
Last Updated
December 1, 2016
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