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Hormone Therapy

Phase 1b Dose Escalation for Prostate Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Nuvation Bio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks throughout study treatment, an average of 6 months
Awards & highlights

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.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks throughout study treatment, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks throughout study treatment, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)
Phase 2 Dose Expansion: Objective response rate (ORR)
Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment2 Interventions
NUV-422 will be administered orally at the RP2cD in combination with enzalutamide. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.
Group II: Phase 1b Dose EscalationExperimental Treatment2 Interventions
NUV-422 will be administered orally at escalating dose levels in combination with enzalutamide until the recommended Phase 2 combination dose (RP2cD) is determined. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

Nuvation Bio Inc.Lead Sponsor
4 Previous Clinical Trials
1,197 Total Patients Enrolled
2 Trials studying Prostate Cancer
731 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
2022. "Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05191017.
~0 spots leftby Jan 2025
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