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

Technical University of Munich1 site in 1 country40 target enrollmentDecember 2007

ConditionsAcute Myeloid Leukemia

DrugsNILOTINIB EVEROLIMUS

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Myeloid Leukemia
Sponsor: Technical University of Munich
Enrollment: 40
Locations: 1
Primary Endpoint: To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective of the study
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

June 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Technical University of Munich

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Time Frame: four years

Secondary Outcomes

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)