To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer

Summary

Participation Requirements

Description

Up to 7 sites in the US only with approximately 18 patients for Phase 1b portion (3 patients per dose group) of the study. Additional patients may be enrolled into the Phase 1b portion of the study depending on the safety and tolerability assessment in the dose escalation scheme. Approximately 26 pa...

Up to 7 sites in the US only with approximately 18 patients for Phase 1b portion (3 patients per dose group) of the study. Additional patients may be enrolled into the Phase 1b portion of the study depending on the safety and tolerability assessment in the dose escalation scheme. Approximately 26 patients will be enrolled in the Phase 2 portion of the study Phase 1b Approximately 18 patients for Phase 1b portion (3 patients per dose group) will be enrolled into the study. Additional subjects may be enrolled based on the assessment of safety and tolerability in the dose escalation scheme. VERU-111 will be administered orally for three 21-day cycles in which the patient will take the study drug (capsules) daily with food for 7 days and then have a 14-day treatment free period. Dose Escalation Criteria In Phase 1b, three patients will be planned at each dose level and followed for one 21-day cycle. If 0/3 patients exhibit a dose limiting toxicity (DLT) after one 21-day cycle, the next patient will be treated at the next dose level. If one patient out of the 3 exhibits a DLT related to the study agent, the cohort will be expanded to up to 6 patients. If 1 of 6 patients exhibits a DLT related to the study agent, then the next patient will enroll at the next dose level. If 2 of the first 3 subjects OR 2 of the first 6 patients exhibit a DLT related to the study agent, the MTD is considered to have been determined and at least 3 additional patients will be entered at the dose level below the one at which DLT is observed. Dose escalations will occur no sooner than 3 weeks after the last patient on the dose level has begun therapy to allow for full assessment of DLT. No intra-patient escalation will be allowed. If <1 of 6 patients experience a DLT, this will be the recommended Phase 2 dose for the expansion cohorts. A Cohort Review Committee, consisting of investigators, the medical monitor and the sponsor, will monitor the trial on an ongoing basis for safety and will guide dose escalation decisions based on the occurrence of DLTs as described in this protocol. The planned dosing for VERU-111 in the Phase 1b portion will be: Treatment Group Daily dose Dosing Regimen 4.5mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. 9mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. 18mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. 27mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. 36mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. 45mg1 Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. 1 If after the first 21-day cycle for the 45 mg in Treatment Group 5 no DLT is observed, then additional dose levels and additional dosing schedules (i.e. 14 days of daily dosing followed by a 7-day treatment free period) may be considered. Phase 2 The maximum tolerated dose of VERU-111 identified in the Phase 1b portion of the study will be used in the Phase 2 portion of the study. The dosing regimen will be daily dosing for 7 days followed by a 14-day treatment free period (21-day cycle). Three 21-day cycles are planned in this study. However, treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.

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