Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC (NCT05191017) | Clinical Trial Compass
WithdrawnPhase 1/2
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Stopped: Sponsor decision
United States0Started 2022-09
Plain-language 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 of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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 criteria
✕. 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
What they're measuring
1
Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)