Phase I/II, open-label, dose-escalating study to evaluate the safety,
tolerability and pharmacokinetics of a twice daily investigational drug" and to evaluate the preliminary clinical and pharmacodynamic response when administered to pediatric patients ages 3 months to less than 18 years of age with one of the following relapsed or refractory leukemia's:
1. MLL (mixed-lineage-leukemia)-rearranged ALL (acute lymphocytic leukemia)
patients
2. FLT3 (FMS-like tyrosine kinase receptor-3) mutated AML (acute myeloid leukemia) patients
An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). This investigational drug may not become commercially available.
Trial phase: phase 1/2
Participation Duration: Participants will be required to visit the study center 7 times during the first one month. If treatment continues, the participant will be asked to come to the office 3 times per month.
Protocol Number: CPKC412A2114