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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT00762632
• Lead Sponsor: Technical University of Munich

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

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Primary Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective of the study	four years

Secondary Outcome Measures

Name	Time	Method
To determine the duration of hematological response. To evaluate overall survival. To evaluate the safety profile of a combination treatment of Nilotinib and RAD001. • To evaluate improvement of symptomatic parameters. • To assess mTor, cKit a	four years

Trial Locations

Locations (1)

Medical faculty of the Technical University Munich; 🇩🇪 Munich, Bavaria, Germany