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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: Gleevec/Glivec (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

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)

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: 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)

Secondary outcome: safety and tolerability of imatinib during the study period

Eligibility

Minimum age: 1 Year. Maximum age: 3 Years. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative Site, Moscow 117997, Russian Federation
Additional Information

Starting date: October 2010
Last updated: March 12, 2012

Page last updated: August 23, 2015

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