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Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC

NCT05191017 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-08-05

No results posted yet for this study

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

DRUG

NUV-422

NUV-422 is an investigational drug for oral dosing.

DRUG

Enzalutamide

Enzalutamide

Sponsors & Collaborators

  • Nuvation Bio Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2025-01-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05191017 on ClinicalTrials.gov