TerminatedPhase 1

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

Russia3 participantsStarted 2010-10

Plain-language summary

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

Who can participate

Age range1 Year – 3 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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)

Timeframe: 2 PK sample collection within 21 days

Trial details

NCT IDNCT01066468

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-05

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