Population Pharmacokinetics of Imatinib in CML Patients i... | NCT02146846

Studies
Population Pharmacokinetics of Imatinib in CML Patients in Iran

NCT02146846

Sponsor

Kerman University of Medical Sciences

Status

Terminated

Last Update Posted

Sep 7, 2016Estimated

Enrollment

170Actual

Phase

Not provided

Conditions

Chronic Myelogenous Leukemia

Interventions

Imatinib

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Apr 2014Actual

Completion Date

Jul 2017Estimated

First Submitted Date

Apr 9, 2014

First Submission Date that Met QC Criteria

May 21, 2014

First Posted Date

May 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ehsan Mohajeri, Assistant of Pharmaceutics, Kerman University of Medical SciencesPrincipal Investigator

Lead Sponsor

Kerman University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imatinib, CML		Patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study	Drug: Imatinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imatinib	Drug	Patients with chronic myeloid leukemia who receive Imatinib as treatment	Imatinib, CML

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ehsan mohajeri, Ph.D.	Department of pharmaceutics, Faculty of pharmacy, Kerman University of medical sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shahid-Bahonar hospital		Kerman	Kerman		Iran

Condition Browse Module

MeSH Terms

ID	Term
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068877	Imatinib Mesylate

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided