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

NCT00762632 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-08-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Justus Prof. Duyster, MD · Medical faculty of the Technical University Munich

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00762632 on ClinicalTrials.gov