Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
Basic Trial Information
|Phase II||Biomarker/Laboratory analysis, Treatment||Active||18 and under||CAMN107A2203|
To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronic
myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).
Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant
to either imatinib or dasatinib
Karnofsky or Lansky ≥ 50
Adequate renal, hepatic and pancreatic function
Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of
Written informed consent
Treatment with strong CYP3A4 inhibitors or inducers
Use or planned use of any medications that have a known risk or possible risk to
prolong the QT interval
Acute or chronic liver, pancreatic or severe renal disease
History of pancreatitis or chronic pancreatitis.
Impaired cardiac function
No evidence of active graft vs host and <3mo since Stem Cell Transplant
Total body irradiation (TBI) or craniospinal radiation therapy <6months
Hypersensitivity to the active ingredient or any of the excipients including lactose.
Other protocol-defined inclusion/exclusion criteria.
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Novartis Pharmaceuticals Corporation
- Innovative Therapies For Children with Cancer Consortium
- Childrens Oncology Group
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01844765
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.