Last updated on December 2016

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Castration-Resistant Prostate Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male
  • Other:
    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
    tudy 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

You may not be eligible for this study if the following are true:

  • Any history of brain metastases or prior seizure or conditions predisposing to
    eizure 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
    tudy 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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