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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Kentucky
Markey Cancer Center
RECRUITING
Lexington
Contact Information
Primary
Yvonne A Taul, RN
Yvonne.Taul@uky.edu
859-323-2354
Time Frame
Start Date: 2024-03-26
Estimated Completion Date: 2025-12
Participants
Target number of participants: 28
Treatments
Experimental: Imatinib TDM
Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.
Related Therapeutic Areas
Sponsors
Leads: Reema A. Patel

This content was sourced from clinicaltrials.gov

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