Imatinib TDM in GIST
ConditionGastrointestinal Stromal Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorReema A. Patel
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Imatinib
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Reema A. Patel
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov