Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of everolimus.
- Determine the toxicity of this regimen.
Secondary
- Assess the activation of PI3K/AKT and mTORC 1 in leukemic blasts.
- Evaluate the pharmacokinetics of everolimus at different concentrations.
OUTLINE: This is a multicenter study.
Patients receive primary induction therapy comprising daunorubicin hydrochloride IV on days
1-3, cytarabine IV over 24 hours on day 1, and oral everolimus on days 1 and 7. Patients
with more than 5% blasts on day 15 receive a second induction course comprising daunorubicin
hydrochloride IV on days 17 and 18 and cytarabine IV twice daily on days 17-20.
After completion of study therapy, patients are followed for 3 months.
Interventional
Primary Purpose: Treatment
Maximum tolerated dose of everolimus
Yes
Sophie Park, MD
Institut de Recherches sur les Leucemies et les Maladies du Sang
Unspecified
CDR0000564068
NCT00544999
September 2007
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