Clinical trial · Interventional
Imatinib TDM in GIST
A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor
NCT05493215CI-TRIAL-00124824recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib TDM
- description
- Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
- Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
- timeFrame
- 6 months
- description
- 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.
Secondary outcomes (3)
- measure
- Percent of patients achieving therapeutic levels of imatinib.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.