3 results
Estimate the maximum tolerated dose (MTD) of AEB071 (dose escalation) and characterize the safety and tolerability of the MTD or recommended Phase 2 dose of AEB071 in patients with metastatic uveal melanoma (dose expansion).
Primary objectivesThe primary objective of the study is demonstrate that at least one of the sotrastaurin treatment arms is non-inferior to the active control regimen myfortic + tacrolimus with respect to composite efficacy failure (treated BPAR of…
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…