Imatinib TDM in GIST

NCT05493215 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-23-GI-131
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percent of patients achieving therapeutic levels of imatinib.

  6 months

• Quality of Life based on the EORTC QLQ-C30

  6 months

• Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years

  3 year

Study Arms (1)

Imatinib TDM

EXPERIMENTAL

Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.

Drug: Imatinib

Interventions

Imatinib DRUG

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

Also known as: Gleevec

Imatinib TDM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reema A. Patel: lead

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Reema Patel, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne A Taul, RN

CONTACT

859-323-2354; Yvonne.Taul@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: March 26, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)