Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Reason given: Sponsor decision
Key facts
- Where
- Canton, Fairfax, and Gettysburg, United StatesSee the 3 sites
- Phase
- Phase 1/2
Where in United States
- Gabrail Cancer Center ResearchCanton, United StatesNo longer taking part
- NEXT VirginiaFairfax, United StatesNo longer taking part
- Pennsylvania Cancer Specialists and Research InstituteGettysburg, United StatesNo longer taking part
Trial details
- Who runs it
- Nuvation Bio Inc.
- Trial code
- NCT05191017
- Record updated
- 5 August 2022
- Original description
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.Read full original descriptionShow less
Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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.
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.