drugset / Trial / NCT00762632

Combination of Nilotinib (AMN107) and RAD001 in Patients With Acute Myeloid Leukemia

NCT00762632

Phase 1/2 Completed 40 enrolled Technical University of Munich
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a nonrandomized, open-label study to evaluate the efficacy and safety of combination treatment of Nilotinib and RAD001 in the treatment of c-kit + AML. Patients refractory to standard chemotherapy or not eligible to standard chemotherapy can be included. Patients will be treated with 400 mg Nilotinib bid (total daily dose 800 mg). RAD001 will be added after a treatment duration of 1 week in a dosage of 2,5 mg/day. Treatment duration will be 25 weeks.

Timeline

Start
2007-12
Primary completion
2012-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 2.5 mg
Subject Nilotinib Small molecule 400 mg