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
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
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
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.
Malignant neoplasm of prostate,
Metastatic Castration Resistant Prostate Cancer
Enzalutamide, Abiraterone, Darolutamide and Apalutamide
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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