A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

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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 Pharmaceuticals, Study Director
    Novartis Pharmaceuticals
    Ph: 1-888-669-6682

    Trial Sites

    U.S.A.

    Alabama
    Birmingham

    UAB Comprehensive Cancer Center

    Joseph Pressey
    Principal Investigator

    California
    Orange

    Children's Hospital of Orange County

    Contact Person
    Ph: 714-532-8824

    Ivan Kirov
    Principal Investigator

    Palo Alto

    Stanford Comprehensive Cancer Center - Palo Alto

    Contact Person
    Ph: 650-723-5535

    Norman Lacayo
    Principal Investigator

    Illinois
    Chicago

    Ann and Robert H. Lurie Children's Hospital of Chicago

    Contact Person
    Ph: 312-227-4779

    Nobuko Hijiya
    Principal Investigator

    Indiana
    Indianapolis

    Riley's Children Cancer Center at Riley Hospital for Children

    Contact Person
    Ph: 317-274-8784

    James Croop
    Principal Investigator

    Ohio
    Cincinnati

    Cincinnati Children's Hospital Medical Center

    Contact Person
    Ph: 513-636-6090

    Maureen O Brien
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01077544
    ClinicalTrials.gov processed this data on May 25, 2015

    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.