Status:
TERMINATED
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00866281
Start Date
September 1 2009
End Date
September 1 2014
Last Update
December 22 2015
Active Locations (8)
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1
Seattle Children's Hospital CPKC412A2114
Seattle, Washington, United States, 98105
2
Novartis Investigative Site
Paris, France, 75935
3
Novartis Investigative Site
Genova, GE, Italy, 16147
4
Novartis Investigative Site
Monza, MB, Italy, 20900