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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05191017
Other study ID # NUV-422-04
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date September 2022
Est. completion date July 2026

Study information

Verified date August 2022
Source Nuvation Bio Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone 2. Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria 3. Have no known active or symptomatic central nervous system (CNS) disease 4. 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 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 2 6. Adequate bone marrow and organ function 7. Eligible to receive enzalutamide 8. Life expectancy of > 6 months Exclusion Criteria: 1. History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma) 2. 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 3. 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 4. 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 5. Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors 6. Known allergy or hypersensitivity to enzalutamide

Study Design


Intervention

Drug:
NUV-422
NUV-422 is an investigational drug for oral dosing.
Enzalutamide
Enzalutamide

Locations

Country Name City State
United States Gabrail Cancer Center Research Canton Ohio
United States NEXT Virginia Fairfax Virginia
United States Pennsylvania Cancer Specialists and Research Institute Gettysburg Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Nuvation Bio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD) Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities During the DLT period (28 days)
Primary Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR) PSA per standard criteria Every 4 weeks throughout study treatment, an average of 6 months
Primary Phase 2 Dose Expansion: Objective response rate (ORR) ORR per standard criteria Every 8 weeks throughout study treatment, an average of 6 months
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