Trial of eRapa in Prostate Cancer Patients
The Phase Ib trial is a dose-escalation study with consecutive enrollment and advancement of cohorts in an overlapping fashion every 6 weeks. Patients will be treated for a total of 3 months with the various dosing regimens as dictated per cohort of the trial. Formal safety assessments, to include safety labs, will be performed in two safety windows: at 4 weeks of treatment of all patients in each dosing cohort prior to enrollment of the next cohort, and again after completion of treatment for each dosing cohort. Additional safety assessments will be performed as needed based on the toxicity profile seen. If any dose limiting toxicity
(DLT) is encountered in the first 3 patients/cohort, an additional 3 patients will be enrolled. If no further patients experience a DLT, then dose escalation will continue. If a second patient experiences a DLT, dose escalation will be halted and the previous dose declared to be the maximum tolerated dose (MTD).