A Phase 1b/2 Study to Evaluate the Safety and Tolerability of VERU-111 in Men with Advanced Metastatic Castration Resistant Prostate Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of Phase I study is to assess the safety and tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic castration-resistant prostate cancer. The purpose of Phase II study is to estimate PSA progression-free survival rate in patients with metastatic castration-resistant prostate cancer patients.
Patient must meet all eligibility criteria to be enrolled in the study. Below is the portion of the study requirements: histological or cytological proof of adenocarcinoma of the prostate; metastatic disease radiographically documented by CT/MRI and/or bone scan. Known castration resistant prostate cancer. Patients who have maintained ADT and have failed a novel androgen receptor agent (abiraterone or enzalutamide). Absolute PSA equal to 2.0 ng/ml. Participants must have normal organ and bone marrow function. Prior treatment with radiation, abiraterone, enzalutamide, bicalutamide, and/or ketoconazole is allowed. There is no limit on the maximum number or types of prior hormonal therapies received. One chemotherapy treatment for metastatic hormone sensitive prostate cancer more than 6 months prior to the trial is allowed.
This is a multi-center, open-label study to evaluate the safety and tolerability of VERU-111. The patients will receive VERU-111 orally daily with food for 7 days and then have a 14-day treatment free period. The patients will be treated for total of 3 cycles. Each cycle is 21 days. The patients will be allowed to continue on the study treatment beyond 3 cycles if benefiting. The patients will be seen in clinic every 3 weeks unless safety visits are required to be done sooner.
08/08/2020 05:02 AM