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Brief Title: Combination of Nilotinib (AMN107) and RAD001 in Patients With Acute Myeloid Leukemia
Official Title: An Open-label Phase I/II (Proof of Concept) Trial of an Combination of Nilotinib (AMN 107) and RAD001 in Patients With Acute Myeloid Leukemia
Study ID: NCT00762632
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical faculty of the Technical University Munich, Munich, Bavaria, Germany
Name: Justus Prof. Duyster, MD
Affiliation: Medical faculty of the Technical University Munich
Role: PRINCIPAL_INVESTIGATOR