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.