A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia - NCT00866281-98105 (Clinical Trial 364341)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy364341.aspx
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| City: |
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Seattle |
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State:
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WA |
| Zip Code: |
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98105 |
| Conditions: |
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Acute Myeloid Leukemia - Acute Lymphoblastic Leukemia |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Mixed-lineage leukemia (MLL) gene rearranged Acute Lympoblastic 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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| Study is available at: |
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Seattle Children's Hospital
Seattle, WA 98105
United States
Primary Contact:
Sara Muchinsky
Email: Sara.muchinsky@seattlechildrens.org
Phone: 206-884-1591
Secondary Contact:
Novartis Pharmaceuticals
Phone: +1 800 340 6843 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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