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

PhaseTypeAgeTrial IDs
Phase IBiomarker/Laboratory analysis, Treatment18 and underCAMN107A2120
NCI-2012-01004, 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:

adequate renal, hepatic and pancreatic function

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

enrollment open only patients 1 < 10 years

Exclusion Criteria:

patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active

graft vs. host disease and < 3 months since SCT

patients who received hematopoietic growth factors within 7 days of starting study

drug or Pegfilgrastim (Neulasta®) within 14 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 imatinib within 5 days of starting study drug

patients who received dasatinib within 3 days of starting study drug

impaired cardiac function

liver, pancreatic or severe renal disease unrelated to disease under study

gastrointestinal impairment or disease that may interfere with drug absorption

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.

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Novartis Pharmaceuticals Corporation

    Trial Sites

    U.S.A.

    Indiana
    Indianapolis

    Indiana University/Melvin and Bren Simon Cancer Center

    James Merrill Croop
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01077544

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.