An Open-Label, Phase II (Proof Of Concept) Trial Of PKC412 Monotherapy In Patients With Acute Myeloid Leukemia (AML) And Patients With High Risk Myelodysplastic Syndrome (MDS)
- Determine the safety, tolerability, and pharmacokinetics of PKC412 with or without
itraconazole in patients with acute myeloid leukemia or high-risk myelodysplastic
- Determine the pharmacodynamic activity of PKC412 on functional FLT3 inhibition in the
cells of these patients.
- Determine the pharmacokinetics and total blood concentration of PKC412 and its
metabolites in these patients.
- Determine the biological and preliminary antitumor activity of these regimens in these
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to FLT3
status (wild type vs mutated). Patients are assigned to 1 of 2 treatment groups.
- Group I: Patients receive oral PKC412 twice daily on days 1-28.
- Group II: Patients receive PKC412 as in group I. Patients also receive oral
itraconazole twice daily on days 22-28.
In both groups, courses repeat every 28 days in the absence of disease progression or
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 24 patients (12 per treatment group) will be accrued for this
Masking: Open Label, Primary Purpose: Treatment
Virginia Klimek, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|