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

Summary

Participation Requirements

Description

This study is a multicenter, randomized, open-label, active-control, efficacy and safety 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. Subjects will have failed t...

This study is a multicenter, randomized, open-label, active-control, efficacy and safety 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. 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.

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