To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
Active, not recruiting
Veru Inc.
Phase 1/Phase 2
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).
COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111
Completed
Veru Inc.
Phase 2
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing
its effect on the proportion of subjects that are alive without respiratory failure at Day
22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen,
intubation and mechanical ventilation, or ventilation with additional organ support (e.g.,
pressors, RRT, ECMO).
VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study
Recruiting
Veru Inc.
Phase 3
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing
its effect on the proportion of patients who die on study (prior to Day 60).
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