Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01066468
First received: February 9, 2010
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to <4 years of age to help develop dosing regimens


Condition Intervention Phase
Chronic Myeloid Leukemia (CML)
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
Drug: Gleevec/Glivec
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Non-randomized, Open-label Study to Characterize the Pharmacokinetics (PK) of Glivec/Gleevec® (Imatinib Mesylate) in Pediatric (Age Range 1 to Less Than 4 Years) Patients With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) or Other Glivec/ Gleevec® Indicated Hematological Disorders (HES, CEL, MDS/ MPN)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Pharmacokinetic data o (CL/F (clearance) o V/F (Volume of distribution) o Tmax o Physiologically based pharmacokinetic (PBPK) parameters (plasma protein binding and α-1 acid glycoprotein concentration) [ Time Frame: 2 PK sample collection within 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety and tolerability of imatinib during the study period [ Time Frame: study period of 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: October 2010
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gleevec/Glivec Drug: Gleevec/Glivec
Other Name: STI571

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be 1 to less than 4 years of age at study entry
  2. Written informed consent must be signed by the patient's parent or legal guardian.
  3. Patients must have the diagnosis of CML or Ph+ ALL
  4. Lansky score must be ≥ 50 (Table7-2)
  5. Patient must have adequate end organ function as defined by

    • Total bilirubin < 1.5 x ULN
    • SGPT (ALT) and SGOT (AST) < 2.5 x UNL
    • Creatinine < 1.5 x ULN

Exclusion Criteria:

  1. Patients who have received drugs a) known to be metabolized by CYP3A4 or 3A5, b) are CYP inhibitors and inducers, within 2 weeks prior to Visit 2 (except for imatinib)
  2. Patients who previously received radiotherapy to ≥ 25% of the bone marrow, with the exception of patients who received total body radiation as part of a preparatory regimen for hematopoetic stem cell transplant (HSCT)
  3. Patients receiving antibacterial and antipyretic medication to treat active infection
  4. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
  5. Patients whose parents or legal guardians, in the opinion of the Investigator, were unlikely to comply with the protocol or safety monitoring requirements

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066468

Locations
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 117997
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01066468     History of Changes
Other Study ID Numbers: CSTI571A2110, 2010-018418-53
Study First Received: February 9, 2010
Last Updated: March 12, 2012
Health Authority: United States: Food and Drug Administration
Hungary: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
Russia: Ministry of Health of the Russian Federation
Canada: Health Canada

Keywords provided by Novartis:
Chronic myeloid leukemia
CML
Philadelphia chromosome positive
acute lymphoblastic leukemia
PhGlivec,
Gleevec,
hypereosinophilic syndrome,
HES,
chronic eosinophilic leukemia,
CEL,
myelodysplastic syndrome,
MDS,
myeloproliferative disease,
MPD+ ALL

Additional relevant MeSH terms:
Leukemia, Myeloid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Disease
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Abnormal Karyotype
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Translocation, Genetic
Chromosome Aberrations
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014