Imatinib TDM in GIST

NCT ID: NCT05493215

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2025-12-31

Brief Summary

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Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.

Detailed Description

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Conditions

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Gastrointestinal Stromal Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imatinib TDM

Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.

Group Type EXPERIMENTAL

Imatinib

Intervention Type DRUG

Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.

Interventions

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Imatinib

Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.

Intervention Type DRUG

Other Intervention Names

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Gleevec

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V)
* Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month
* Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease
* Age ≥18 years
* ECOG performance status of 0 or 1
* Normal organ function

Exclusion Criteria

* Presence of PDGFRA D842V mutation
* Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug
* Concomitant anticoagulation with oral warfarin.
* Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6
* Uncontrolled intercurrent illness
* Concurrent malignancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reema A. Patel

OTHER

Sponsor Role lead

Responsible Party

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Reema A. Patel

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Reema Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Markey Cancer Center

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yvonne A Taul, RN

Role: CONTACT

859-323-2354

Facility Contacts

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Yvonne Taul, RN

Role: primary

859-323-7628

Other Identifiers

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MCC-23-GI-131

Identifier Type: -

Identifier Source: org_study_id

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