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To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer

NCT03752099 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-09-26

No results posted yet for this study

Summary

Phase 1b - To assess the safety/tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic, castration resistant prostate cancer who have failed a novel androgen blocking agent therapy (mCRPC).

Phase 2 - To estimate the PSA50 response rate, defined as a decline in PSA to ≥50% of baseline level, confirmed with a second measurement at least 3 weeks apart (PCWG3).

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DRUG

VERU-111

VERU-111

Sponsors & Collaborators

  • Veru Inc.

    lead INDUSTRY

Principal Investigators

  • Barnette · Veru Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-18
Primary Completion
2023-03-15
Completion
2023-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03752099 on ClinicalTrials.gov