Population Pharmacokinetics of Imatinib in CML Patients in Iran

Terminated

• Conditions: Chronic Myelogenous Leukemia
• Interventions: Drug: Imatinib

• Registration Number: NCT02146846
• Lead Sponsor: Kerman University of Medical Sciences

Brief Summary

The purpose of this study is to determine population Pharmacokinetics and differences and variation of pharmacokinetics parameters of Imatinib as a tyrosine kinase inhibitor in treatment of chronic myeloid leukemia patients in Iranian population.

Detailed Description

patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study then population pharmacokinetics parameters is determined.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-04
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• patient in chronic phase of myeloid leukemia
• no liver and renal failure

Exclusion Criteria

• multiple dug treatment
• previous treatment of interferon
• patients in blast or accelerated phase

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Imatinib, CML	Imatinib	Patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study

Primary Outcome Measures

Name	Time	Method
Percent of changes of AUC, trough Concentration from predicted values	Blood sampling are collected on atleast the 30th day of treatment at the following time: 1 hour before the dose and 1 hour after the dose	The influence of patients' characteristic on the pharmacokinetics of Imatinib will be assessd.

Trial Locations

Locations (1)

Shahid-Bahonar hospital; 🇮🇷 Kerman, Iran, Islamic Republic of