A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
| Status: | Terminated |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | September 2014 |
A Phase I/II, Open-label, Dose-escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Twice Daily Oral Midostaurin and to Evaluate the Preliminary Clinical and Pharmacodynamic Response in Pediatric Patients With Relapsed or Refractory Leukemia
This is a phase I/II pediatric dose-ranging study that will evaluate the safety,
tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in
patients <18 years of age who have relapsed or refractory acute leukemias that may benefit
from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.
tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in
patients <18 years of age who have relapsed or refractory acute leukemias that may benefit
from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.
Inclusion Criteria:
- Mixed-lineage leukemia (MLL) gene rearranged Acute Lymphoblastic Leukemia (ALL), that
does not respond to treatment or has relapsed from prior treatment; or FLT3 mutated
Acute Myeloid Leukemia (AML) that does not respond to a second treatment or has
relapsed from 2 prior treatments
- Normal organ function, and chest x-ray
- Expected survival greater than 8 weeks
- Can care for most of personal needs and perform at least minimum activity
Exclusion Criteria:
- Patients with symptomatic leukemic central nervous system involvement or isolated
extramedullary leukemia
- Patients must not have received other treatments for leukemia within a predefined
time period, 72 hours for medications, 2 months for transplants
- Patients with heart function that is not normal
- Patients with HIV or hepatitis
- Patients with another severe disease or medical condition besides leukemia Other
protocol-defined inclusion/exclusion criteria may apply
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