drugset / Trial / NCT02273219

Trial of AEB071 in Combination With BYL719 in Patients With Melanoma

NCT02273219

Phase 1 Completed 30 enrolled Columbia University
Non-randomizedSequentialOpen-labelTreatment

Summary

Primary objective is to define the maximum tolerated dose (MTD) for the combination of AEB071 and BYL719. Secondary objectives are to define the safety and tolerability of AEB071 and BYL719.

Timeline

Start
2014-11-19
Primary completion
2017-10-18
Completion
2018-07-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule 200 mg Oral
Subject Alpelisib Small molecule 250 mg Oral
Subject Alpelisib Small molecule 300 mg Oral
Subject Alpelisib Small molecule 350 mg Oral
Subject sotrastaurin Small molecule 100 mg Oral
Subject sotrastaurin Small molecule 200 mg Oral
Subject sotrastaurin Small molecule 300 mg Oral

Indications