Imatinib TDM in GIST

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493215
• Other study ID #: MCC-23-GI-131
• Status: Recruiting
• Phase: Phase 2
• Start date: March 26, 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University of Kentucky
• Contact: Yvonne A Taul, RN
• Phone: 859-323-2354
• Email: Yvonne.Taul[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Imatinib
Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.

Locations

Country	Name	City	State
United States	Markey Cancer Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Reema A. Patel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0	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.	6 months
Secondary	Percent of patients achieving therapeutic levels of imatinib.	Percent of patients achieving therapeutic levels of imatinib.	6 months
Secondary	Quality of Life based on the EORTC QLQ-C30	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.	6 months
Secondary	Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years		3 year