NCT00762632

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	NILOTINIB	400 mg Nilotinib bid (total daily dose 800 mg) should be continued 25 weeks
DRUG	EVEROLIMUS	Everolimus at 2,5 mg/day should be continued 25 weeks.

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-06-01
• First posted: 2008-09-30
• Last updated: 2012-08-08

Locations

1 site across 1 country: Germany