A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)
Basic Trial Information
|Phase I||Biomarker/Laboratory analysis, Treatment||Active||18 and under||Pharmaceutical / Industry||CAMN107A2120|
This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.
- enrollment open only patients 1 < 10 years
- Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/ intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or refractory to standard therapy
- adequate renal, hepatic and pancreatic function
- patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and treatments cannot be stopped or changed to a different medication at least 14 days prior to starting study drug
- patients receiving therapy with any medications with a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
- gastrointestinal impairment or disease that may interfere with drug absorption
- liver, pancreatic or severe renal disease unrelated to disease under study
- impaired cardiac function
- patients who received dasatinib within 3 days of starting study drug
- patients who received imatinib within 5 days of starting study drug
- patients receiving hydroxyurea or corticosteroids that has not been discontinued at least 1 week after initiation of nilotinib
- patients who received hematopoietic growth factors within 7 days of starting study drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drug
- patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active graft vs. host disease and < 3 months since SCT
Other protocol-defined inclusion/exclusion criteria may apply
Trial Contact Information
Trial Lead Organizations/Sponsors
Novartis Pharmaceuticals Corporation
UAB Comprehensive Cancer Center
Children's Hospital of Orange County
Stanford Comprehensive Cancer Center - Palo Alto
Ann and Robert H. Lurie Children's Hospital of Chicago
Riley's Children Cancer Center at Riley Hospital for Children
Cincinnati Children's Hospital Medical Center
Maureen O Brien
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01077544
ClinicalTrials.gov processed this data on April 27, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.