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Clinical Trials (PDQ®)

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
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, TreatmentActive18 and underPharmaceutical / IndustryCAMN107A2120
2010-018419-14, NCT01077544

Trial Description

Summary

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.

Eligibility Criteria

Inclusion Criteria:

  • 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

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 PharmaceuticalsStudy Director

Novartis PharmaceuticalsPh: 1-888-669-6682

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Joseph PresseyPrincipal Investigator
California
  Orange
 Children's Hospital of Orange County
 Contact Person Ph: 714-532-8824
 Ivan KirovPrincipal Investigator
  Palo Alto
 Stanford Comprehensive Cancer Center - Palo Alto
 Contact Person Ph: 650-723-5535
 Norman LacayoPrincipal Investigator
Illinois
  Chicago
 Ann and Robert H. Lurie Children's Hospital of Chicago
 Contact Person Ph: 312-227-4779
 Nobuko HijiyaPrincipal Investigator
Indiana
  Indianapolis
 Riley's Children Cancer Center at Riley Hospital for Children
 Contact Person Ph: 317-274-8784
 James CroopPrincipal Investigator
Ohio
  Cincinnati
 Cincinnati Children's Hospital Medical Center
 Contact Person Ph: 513-636-6090
 Maureen O'BrienPrincipal Investigator
Brazil
Sao Paulo
  Barretos
 Novartis Investigative Site
  Sao Paulo
 Novartis Investigative Site
  São Paulo
 Novartis Investigative Site
France
  Bordeaux
 Novartis Investigative Site
  Paris Cedex 19
 Novartis Investigative Site
  Poitiers
 Novartis Investigative Site
Germany
  Dresden
 Novartis Investigative Site
Italy
  Genova
 Novartis Investigative Site
  Monza
 Novartis Investigative Site
  Padova
 Novartis Investigative Site
  Roma
 Novartis Investigative Site
Netherlands
  Amsterdam
 Novartis Investigative Site
  Rotterdam
 Novartis Investigative Site
Republic of Korea
  Seoul
 Novartis Investigative Site
Russia
  Moscow
 Novartis Investigative Site
Thailand
  Bangkok
 Novartis Investigative Site
United Kingdom
  Birmingham
 Novartis Investigative Site
  Bristol
 Novartis Investigative Site
  Manchester
 Novartis Investigative Site
  Sutton
 Novartis Investigative Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01077544
ClinicalTrials.gov processed this data on September 18, 2014

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.

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