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Recruiting NCT05493215

Imatinib TDM in GIST

Phase II Interventional Gastrointestinal Stromal Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Imatinib.
Who it may be relevant to
Registry conditions: Gastrointestinal Stromal Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 [Time frame: 6 months]
Secondary outcome measures (3)
  • Percent of patients achieving therapeutic levels of imatinib. [Time frame: 6 months]
  • Quality of Life based on the EORTC QLQ-C30 [Time frame: 6 months]
  • Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years [Time frame: 3 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Markey Cancer Center — Lexington

Identifiers

NCT: NCT05493215 · MCC-23-GI-131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗