Status:
WITHDRAWN
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Lead Sponsor:
Nuvation Bio Inc.
Conditions:
Prostate Cancer
Prostatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised o...
Eligibility Criteria
Inclusion
- Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
- Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria
- Have no known active or symptomatic central nervous system (CNS) disease
- Prior therapy with abiraterone required and:
- For Phase 1b only: up to 2 prior taxane-based chemotherapy regimens allowed for castration-resistant disease
- For Phase 2 only: Patients must not have received prior taxane-based chemotherapy for castrate-resistant disease or prior treatment with CDK inhibitors
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- Adequate bone marrow and organ function
- Eligible to receive enzalutamide
- Life expectancy of \> 6 months
Exclusion
- History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma)
- Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs) radiation, or biological anti-cancer therapy within 14 days prior to first dose of NUV-422 and enzalutamide
- Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or \< 5 half-lives) for myelosuppressive agent prior to the first dose of NUV-422 and enzalutamide
- Requires medications that are known to be strong inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide
- For Phase 1b only: Requires medications that are known to be moderate inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide
- Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors
- Known allergy or hypersensitivity to enzalutamide
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05191017
Start Date
September 1 2022
End Date
July 1 2026
Last Update
August 5 2022
Active Locations (3)
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1
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
2
Pennsylvania Cancer Specialists and Research Institute
Gettysburg, Pennsylvania, United States, 17325
3
NEXT Virginia
Fairfax, Virginia, United States, 22031