A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refrac… (NCT00866281) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
Stopped: Despite considerable efforts to boost recruitment during the final year of the study, no new patients were enrolled.
United States, France, Italy22 participantsStarted 2009-09
Plain-language summary
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.
Who can participate
Age range3 Months – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Maximum Tolerated Dose (MTD) of Midostaurin- Posterior Probability of DLT
Timeframe: Baseline, End of dose escalation phase (6 months)