Imatinib TDM in GIST
A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor
Reema A. Patel
28 participants
Mar 26, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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
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Interventions
Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05493215