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

NCT ID: NCT01066468

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Gleevec/Glivec

Group Type: EXPERIMENTAL

Gleevec/Glivec

Intervention Type: DRUG

Interventions

Gleevec/Glivec

Intervention Type: DRUG

Other Intervention Names

STI571

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Moscow, , Russia

Countries

Russia

Other Identifiers

2010-018418-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSTI571A2110

Identifier Type: -

Identifier Source: org_study_id