Study Results
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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RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2024-03-26
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Imatinib TDM
Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.
Imatinib
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Reema A. Patel
OTHER
Responsible Party
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Reema A. Patel
Assistant Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MCC-23-GI-131
Identifier Type: -
Identifier Source: org_study_id
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