Recruiting
Phase 2

Imatinib

Sponsor:

Reema A. Patel

Code:

NCT05493215

Conditions

Gastrointestinal Stromal Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Imatinib

Study Details

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

Study ID

NCT05493215

Start date

Mar 26, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Imatinib TDM

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

Interventions

Imatinib

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

Primary outcome measure

  • Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Yvonne A Taul, RN

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

Locations

Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Yvonne Taul, RN

859-323-7628yvonne.taul@uky.edu

More Information

Sponsor

Reema A. Patel

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reema A. Patel on 2026-08-31.