RECRUITING

Imatinib TDM in GIST

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-26

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05493215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Yvonne A Taul, RN

CONTACT

859-323-2354

Yvonne.Taul@uky.edu

Principal Investigator

Reema Patel, MD

PRINCIPAL_INVESTIGATOR

University of Kentucky

Study Locations (Sites)

Markey Cancer Center

Lexington, Kentucky, 40536

United States

Collaborators and Investigators

Sponsor: Reema A. Patel

Reema Patel, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-26

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-03-26

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Gastrointestinal Stromal Tumors