Population Pharmacokinetics of Imatinib in CML Patients in Iran

NCT02146846 | Terminated DMC

• 1 other identifier: Kerman-001-FOPPT
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myelogenous Leukemia

Keywords

cml

Outcome Measures

Primary Outcomes (1)

• Percent of changes of AUC, trough Concentration from predicted values

  The influence of patients' characteristic on the pharmacokinetics of Imatinib will be assessd.

  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

Study Arms (1)

Imatinib, CML

Patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study

Drug: Imatinib

Interventions

Imatinib DRUG

Patients with chronic myeloid leukemia who receive Imatinib as treatment

Also known as: Glivec

Imatinib, CML

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with approved diagnosis of chronic myeloid leukemia taking Imatinib as treatment

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kerman University of Medical Sciences: lead

Study Sites (1)

Shahid-Bahonar hospital

Kerman, Kerman, Iran

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• ehsan mohajeri, Ph.D.

  Department of pharmaceutics, Faculty of pharmacy, Kerman University of medical sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant of Pharmaceutics

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: May 26, 2014
• Study Start: October 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2017
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

IR (1)