Imatinib TDM in GIST

Purpose

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.

Condition

  • Gastrointestinal Stromal Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Imatinib TDM 		Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.
  • Drug: Imatinib
    Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.
    Other names:
    • Gleevec

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Yvonne Taul, RN
859-323-7628
yvonne.taul@uky.edu

More Details

NCT ID
NCT05493215
Status
Recruiting
Sponsor
Reema A. Patel

Study Contact

Yvonne A Taul, RN
859-323-2354
Yvonne.Taul@uky.edu