臨床研究等提出・公開システム

A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib

Study of efficacy and safety of nilotinib in pediatric CML patients

Yes

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Novartis Pharma

1-23-1, Toranomon, Minato-ku, Tokyo

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Novartic Pharma

1-23-1, Toranomon, Minato-ku, Tokyo

+81-120-003-293

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completed

Aug. 20, 2013

Interventional

single arm, open label, multi-center

treatment purpose

2

1. Male or female patients from 1 year of age to less than 18 years of age at study entry
2. Patients must have the diagnosis of newly diagnosed Ph+ CML-CP or Ph+CML-CP or AP resistant or intolerant to either imatinib or dasatinib
3. Performance status: Karnofsky >= 50% for patients > 10 years of age, and Lansky >= 50 for patients <= 10 years of age
4. Patients must have adequate renal, hepatic and pancreatic function
5. Patients must have potassium, magnesium, phosphorus and total calcium values >= LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication
6. Written informed consent must be obtained prior to any screening procedures

-Patients actively receiving therapy with strong CYP3A4 inhibitors or inducers and the treatment cannot be either discontinued or switched to a different medication at least 14 days prior to starting study drug.
-Patients who are currently receiving treatment with any medications that have 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.
-Acute or chronic liver, pancreatic or severe renal disease considered unrelated to CML.
-History of pancreatitis within 12 months of starting study drug or past medical history of chronic pancreatitis.
-In case of Stem Cell Transplant (SCT) or Rescue without total body irradiation (TBI): Evidence of either active graft vs. host disease or less than 3 months since SCT.
-Patients who have a known hypersensitivity to the active ingredient or any of the excipients including lactose.

Both

Male or female pediatric patients (1 to <18 years of age) with newly diagnosed Ph+ CML-CP (at least 15 patients) or with Ph+ CML in CP (at least 15 patients) or AP (no minimum number specified) resistant or intolerant to imatinib or dasatinib.

investigational material(s)
Generic name etc : AMN107 (Nilotinib)
INN of investigational material : Nilotinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : twice daily, 230 mg/m2 orally

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
-

safety
-

-

July. 23, 2013