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RECRUITING Phase 2 ClinicalTrials.gov

Imatinib TDM in GIST

Sponsor: Reema A. Patel • ClinicalTrials.gov ID: NCT05493215

Registry updated: 2026-08-31
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Description

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.

Interventions

  • Imatinib (Drug)
    Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.

Eligibility criteria

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

Conditions

Gastrointestinal Stromal Tumors

Locations

  • Markey Cancer Center — Lexington, Kentucky, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record