Trials / Withdrawn
WithdrawnNCT05191017
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Nuvation Bio Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Prostate Cancer
- Prostatic Cancer
- Cancer of Prostate
- Cancer of the Prostate
- Prostate Neoplasm
- Castrate Resistant Prostate Cancer
- Castration Resistant Prostatic Cancer
- Castration Resistant Prostatic Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NUV-422 | NUV-422 is an investigational drug for oral dosing. |
| DRUG | Enzalutamide | Enzalutamide |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2025-01-01
- Completion
- 2026-07-01
- First posted
- 2022-01-13
- Last updated
- 2022-08-05
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05191017. Inclusion in this directory is not an endorsement.