NCT01066468

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

February 9, 2010

Last Update Submit

March 12, 2012

Conditions

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

Keywords

Chronic myeloid leukemiaCMLPhiladelphia chromosome positiveacute lymphoblastic leukemiaPhGlivec,Gleevec,hypereosinophilic syndrome,HES,chronic eosinophilic leukemia,CEL,myelodysplastic syndrome,MDS,myeloproliferative disease,MPD+ ALL

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 PK sample collection within 21 days

Secondary Outcomes (1)

  • safety and tolerability of imatinib during the study period

    study period of 21 days

Study Arms (1)

Gleevec/Glivec

EXPERIMENTAL
Drug: Gleevec/Glivec

Interventions

Gleevec/GlivecDRUG
Also known as: STI571
Gleevec/Glivec

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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)
  • 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)
  • Patients receiving antibacterial and antipyretic medication to treat active infection
  • 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
  • Patients whose parents or legal guardians, in the opinion of the Investigator, were unlikely to comply with the protocol or safety monitoring requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Moscow, 117997, Russia

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveHypereosinophilic SyndromePrecursor Cell Lymphoblastic Leukemia-LymphomaPdgfra-Associated Chronic Eosinophilic LeukemiaMyelodysplastic SyndromesMyeloproliferative Disorders

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEosinophiliaLeukocyte DisordersLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

October 1, 2010

Primary Completion

May 1, 2011

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

RU(1)