NCT04844749

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

VERACITY - Randomized, Active-Controlled, Phase 3 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Veru Inc. · Industry
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a multicenter, randomized, open-label, active-control, efficacy and safety study of VERU-111 (Sabizabulin) for the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent. Subjects will have failed treatment with at least one prior androgen receptor targeting agent and be eligible for treatment with an alternative androgen receptor targeting agent (as per the current standard of care for these patients). Subjects will be randomized in a 2:1 ratio to receive VERU-111 or Active Control (alternative androgen receptor targeting agent). Subjects in the VERU-111 treated group will receive VERU-111 32 mg per day orally with an option to reduce the dose to 26 mg per day based on tolerability to the 32 mg dose until radiographic progression (blinded independent central read) in observed. Subjects in the Control treated group will receive an alternative androgen receptor targeting agent with dose and dosing regimen defined in the FDA approved prescribing information until radiographic progression in observed. Randomization will be stratified by measurable disease vs. bone-only disease. A significant proportion (\>30%) of the patients randomized into the study will have measurable disease at baseline. Randomization will also be stratified by if the patient has failed one vs. more than one prior androgen targeting agent. The primary efficacy endpoint of the study will be radiographic progression free survival.

Conditions

• Metastatic Castration-resistant Prostate Cancer
• Androgen Resistant Prostatic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-24
• Primary completion: 2023-05-04
• Completion: 2023-05-04
• First posted: 2021-04-14
• Last updated: 2024-02-05

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study