Open label, phase II study to evaluate efficacy and safety of oral nilotinib in Philadelphia positive (Ph+) chronic myelogenous leukemia (CML) pediatric patients.

• Conditions: newly diagnosed Ph+ chronic myelogenousleukemia (CML) in chronic phase (CP) or Ph+ CML inCP or accelerated phase (AP) resistant or intolerant toeither imatinib or dasatinib- bone marrow disease; MedDRA version: 14.1Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000200-41-IT
• Lead Sponsor: OVARTIS FARMA S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-27
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients eligible for inclusion in this study have to meet all of the following criteria; additional inclusion criteria may apply as per protocol:
1. Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib
2. Karnofsky or Lansky = 50
3. Adequate renal, hepatic and pancreatic function
4. Potassium, magnesium, phosphorus and total calcium values = LLN (lower limit of normal)
5. Written informed consent

Additional inclusion criteria are defined in the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients eligible for this study must not meet any of the following criteria:
1. Treatment with strong CYP3A4 inhibitors or inducers
2. Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval
3. Acute or chronic liver, pancreatic or severe renal disease
4. History of pancreatitis or chronic pancreatitis.
5. Impaired cardiac function
6. No evidence of active graft vs host and <3mo since Stem Cell Transplant
7. Total body irradiation (TBI) or craniospinal radiation therapy <6months 8. Hypersensitivity to the active ingredient or any of the excipients including lactose

Additional exclusion criteria are defined in the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified