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

Completed · Phase 1

Conditions studied: Metastatic Castration-Resistant Prostate Cancer

In brief

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

Key facts

Study ID

NCT02705469

Run by

Zenith Epigenetics

People needed

44

Starts

2016-05-01

Expected to finish

2017-10-01

Last updated by the study team

2017-11-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 study 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 qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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