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Imatinib Therapeutic Drug Monitoring in GIST

This study is looking at how to improve treatment for people with Gastrointestinal Stromal Tumors (GIST). It will test a drug called imatinib. Researchers will monitor the levels of imatinib in your body and adjust your dose based on these levels and your symptoms. The goal is to improve your quality of life and reduce side effects while making sure the drug is working effectively. To join, you need to be at least 18 years old and have GIST with specific genetic changes (KIT or PDGFRA mutation, not D842V). You should also be starting imatinib soon or have started it within the last three months. The study aims to enroll 28 participants, but its current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 28 participants. It focuses on adjusting imatinib dosage based on drug levels and patient symptoms.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, measuring severe side effects, will be assessed at 6 months.

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NCT05493215

Imatinib TDM in GIST

Recruiting
PHASE2Ages 18+InterventionalTreatment
Reema A. Patel
~28 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Imatinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
Measured over 6 months

Conditions

Gastrointestinal Stromal Tumors

Explore related trials

Gastrointestinal Stromal TumorKIT GenePDGFRA Gene

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Reema Patel, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Yvonne A Taul, RN
[email protected]
859-323-2354
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.06 months

    To compare the incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 in patients who receive therapeutic drug monitoring (TDM) with imatinib to a historical control.