A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT02705469
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2016-05-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation and Dose Confirmation - ZEN003694 Single Agent
ZEN003694 will be administered orally as a single agent once daily in 28-day cycles, enrolling mCRPC patients.
ZEN003694
Interventions
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ZEN003694
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
18 Years
MALE
No
Sponsors
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Zenith Epigenetics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ZEN003694-001
Identifier Type: -
Identifier Source: org_study_id