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NCT Number: NCT05493215

Imatinib TDM in GIST

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.

Recruiting

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Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location status: Recruiting

Location contact

Yvonne Taul, RN

CONTACT

[email protected]

859-323-7628

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imatinib

Drug

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

Other names: Gleevec

Primary outcomes

  1. Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0

    Time frame: 6 months

    To compare the incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 in patients who receive therapeutic drug monitoring (TDM) with imatinib to a historical control.

Secondary outcomes

  1. Percent of patients achieving therapeutic levels of imatinib.

    Time frame: 6 months

    Percent of patients achieving therapeutic levels of imatinib.

  2. Quality of Life based on the EORTC QLQ-C30

    Time frame: 6 months

    Quality of Life will be assessed using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions. It incorporates five functional scales, three symptom scales, a global health status, financial impact, and single items assessing additional symptoms. All scales and single-item measures are transformed so that scores range from 0-100; higher scores represent a higher response level.

  3. Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years

    Time frame: 3 year

Study contacts

Contact information is provided by the study sponsor or research team.

Yvonne A Taul, RN

CONTACT

[email protected]

859-323-2354

Sponsors and collaborators

Lead sponsor

Reema A. Patel

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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