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Trial Title:
Imatinib TDM in GIST
NCT ID:
NCT05493215
Condition:
Gastrointestinal Stromal Tumors
Conditions: Official terms:
Gastrointestinal Stromal Tumors
Imatinib Mesylate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Imatinib
Description:
Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on
levels and patient symptoms.
Arm group label:
Imatinib TDM
Other name:
Gleevec
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Markey Cancer Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yvonne Taul, RN
Phone:
859-323-7628
Email:
yvonne.taul@uky.edu
Start date:
March 26, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Reema A. Patel
Agency class:
Other
Source:
University of Kentucky
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05493215