An Open-label Phase I/II (Proof of Concept) Trial of PKC412 in Patients With Acute Myeloid Leukemia (AML) and Patients With High Risk Myelodysplastic Syndrome (MDS) With Either Wild Type or Mutated FLT3
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate preliminary anti-tumor activity in AML and MDS patients with wild type or mutated FLT3 receiving continuous twice-daily oral dose of either 50 or 100 mg who have not previously received a FLT3 inhibitor.
Day 28 of Cycle 2
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CPKC412A2104E1
NCT00977782
March 2003
October 2008
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Dana Faber Cancer Institute | Boston, Massachusetts 02115 |
Memorial Slon-Kettering Cancer Center | New York, New York 10065 |
Cornell Comprehensive Cancer Center | New York, New York 10065 |