Imatinib TDM in GIST

Last updated: March 28, 2024
Sponsor: Reema A. Patel
Overall Status: Active - Recruiting

Phase

2

Condition

Gastric Cancer

Abdominal Cancer

Gastrointestinal Diseases And Disorders

Treatment

Imatinib

Clinical Study ID

NCT05493215
MCC-23-GI-131
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 inthe next 1 month
  • Prior systemic chemotherapy for other malignancy is allowed as long as it wascompleted 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

Exclusion Criteria:

  • Presence of PDGFRA D842V mutation
  • Known allergy to imatinib or allergic reactions to compounds of similar chemical orbiologic composition to the study drug
  • Concomitant anticoagulation with oral warfarin.
  • Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4or CYP2D6
  • Uncontrolled intercurrent illness
  • Concurrent malignancy

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: Imatinib
Phase: 2
Study Start date:
March 26, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

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