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Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent

NCT04844749 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-02-05

No results posted yet for this study

Summary

To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured by radiographic progression-free survival.

Conditions

Interventions

DRUG

VERU-111

Based on the safety and antitumor activity of VERU-111 in the Phase 1b/2 clinical study, VERU-111 is initiating this Phase 3 clinical study of VERU-111 for the treatment of metastatic castration resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent

DRUG

Enzalutamide, Abiraterone

Enzalutamide and abiraterone were chosen as active comparators are both are FDA approved for the treatment of metastatic castration resistant prostate cancer

Sponsors & Collaborators

  • Veru Inc.

    lead INDUSTRY

Principal Investigators

  • Barnette · Veru Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2023-05-04
Completion
2023-05-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04844749 on ClinicalTrials.gov