Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This study will assess the pharmacokinetics of nilotinib in pediatric patients with resistant/intolerance Ph+ CML chronic phase or accelerated phase (CP or AP) and refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.

Eligibility Criteria

Inclusion Criteria:

• patients < 18 years

• imatinib resistant or intolerant Ph+ CML CP or AP or Ph+ ALL either relapsed after or refractory to standard therapy

• adequate renal, hepatic and pancreatic function

Exclusion Criteria:

• 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

Novartis Pharmaceuticals

Study Director

Novartis Pharmaceuticals

Ph: 1-888-669-6682

U.S.A.
Illinois
	Chicago
	Ann and Robert H. Lurie Children's Hospital of Chicago
		Contact Person	Ph: 312-227-4779
		Nobuko Hijiya	Principal Investigator
France
	Bordeaux
	Novartis Investigative Site
	Lille cedex
	Novartis Investigative Site
	Paris
	Novartis Investigative Site
	Paris Cedex 19
	Novartis Investigative Site
	Poitiers
	Novartis Investigative Site
Italy
	Monza
	Novartis Investigative Site
	Padova
	Novartis Investigative Site
	Roma
	Novartis Investigative Site
Netherlands
	Rotterdam
	Novartis Investigative Site
United Kingdom
	Birmingham
	Novartis Investigative Site
	Bristol
	Novartis Investigative Site
	Sutton
	Novartis Investigative Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01077544
Information obtained from ClinicalTrials.gov on May 22, 2013

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