Imatinib TDM in GIST

Phase 2

Recruiting

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Drug: Imatinib

• Registration Number: NCT05493215
• Lead Sponsor: Reema A. Patel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-09
• Study Start: 2024-03-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imatinib TDM	Imatinib	Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.

Primary Outcome Measures

Name	Time	Method
Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0	6 months	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 Outcome Measures

Name	Time	Method
Percent of patients achieving therapeutic levels of imatinib.	6 months	Percent of patients achieving therapeutic levels of imatinib.
Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years	3 year
Quality of Life based on the EORTC QLQ-C30	6 months	Quality of Life will be assessed using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions. It incorporates five functional scales, three symptom scales, a global health status, financial impact, and single items assessing additional symptoms. All scales and single-item measures are transformed so that scores range from 0-100; higher scores represent a higher response level.

Trial Locations

Locations (1)

Markey Cancer Center; 🇺🇸 Lexington, Kentucky, United States