A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia - NCT00866281-02115 (Clinical Trial 364340)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy364340.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Boston |
|
State:
|
|
MA |
| Zip Code: |
|
02115 |
| Conditions: |
|
Acute Myeloid Leukemia - Acute Lymphoblastic Leukemia |
| Purpose: |
|
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.
|
| Study summary: |
|
|
| Criteria: |
|
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 |
|
|
|
| Study is available at: |
|
Dana Faber Cancer Institute, Children's Hospital, Dept. of Pediatric Oncology
Boston, MA 02115
United States
Primary Contact:
Jane E. O'Brien, CCRP
Email: jane_obrien@dfci.harvard.edu
Phone: 617-632-3549
Secondary Contact:
Novartis Pharmaceuticals
Phone: +1 800 340 6843 |
|
|
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.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
November 16, 2009 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|