To hear about similar clinical trials, please enter your email below

Trial Title: Imatinib TDM in GIST

NCT ID: NCT05493215

Condition: Gastrointestinal Stromal Tumors

Conditions: Official terms:
Gastrointestinal Stromal Tumors
Imatinib Mesylate

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Imatinib
Description: Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.
Arm group label: Imatinib TDM

Other name: Gleevec

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Markey Cancer Center

Address:
City: Lexington
Zip: 40536
Country: United States

Status: Recruiting

Contact:
Last name: Yvonne Taul, RN

Phone: 859-323-7628
Email: yvonne.taul@uky.edu

Start date: March 26, 2024

Completion date: December 2025

Lead sponsor:
Agency: Reema A. Patel
Agency class: Other

Source: University of Kentucky

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05493215

Login to your account

Did you forget your password?