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Evaluating Imatinib Treatment After 10 Years for GIST Patients

Randomized, Multicentre, Phase II Study Evaluating the Interest of Imatinib Treatment Maintenance or Interruption After at Least 10 Years of Treatment in Patients With Locally Advanced/Metastatic Gastrointestinal Stromal Tumors (GISTs)

Phase 2 Interventional Centre Leon Berard · NCT05009927

This study is testing whether stopping or continuing imatinib treatment helps people with advanced gastrointestinal stromal tumors who have been on the medication for at least 10 years.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Leon Berard Academic / other
Drugs / interventionsimatinib
Locations13 sites (Besançon and 12 other locations)
Trial IDNCT05009927 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of continuing or discontinuing imatinib treatment in patients with advanced or metastatic gastrointestinal stromal tumors (GIST) who have been on the medication for at least 10 years. Participants are divided into two groups: one will stop imatinib to assess the potential for reintroduction upon disease relapse, while the other will continue treatment to evaluate its efficacy in preventing disease progression. The study aims to provide insights into the optimal duration of imatinib therapy for GIST patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of advanced or metastatic GIST who have been on imatinib for 10 years or more without significant interruptions.

Not a fit: Patients who have not been on imatinib for the required duration or those with uncontrolled disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help determine the best treatment strategy for long-term GIST patients, potentially improving their disease management.

How similar studies have performed: Previous studies have shown that continuous imatinib treatment significantly reduces disease progression compared to treatment interruption, indicating that this approach is based on established findings.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients ≥18 years of age;
* Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;
* Eastern Cooperative Oncology Group (ECOG) - Performance status (PS) 0 to 2 evaluated within 7 days prior to the date of inclusion.
* Patient must be under imatinib treatment (at 300 or 400mg/day) maintained for 10 years or over with no more than 12 months in total or 3 consecutive months of interruption during the treatment period;
* Patient with controlled disease (without any progression under imatinib);
* Willingness and ability to comply with scheduled visits, treatment plans , laboratory tests, and other study procedures;
* Covered by a medical/health insurance;
* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.

Exclusion Criteria:

* Patient concurrently using other approved or investigational antineoplastic agents;
* Patient with GIST harboring the mutation D842V in PDGFRA;
* Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;
* Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years;
* Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;
* Major surgery within 2 weeks prior to study entry.
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
* Pregnant or breastfeeding woman
* Patient requiring tutorship or curatorship or patient deprivied of liberty.

Where this trial is running

Besançon and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Gastrointestinal Stromal TumorC-KIT MutationAdvanced Gastrointestinal Stromal TumorGastrointestinal Stromal TumorsTyrosine kinase inhibitorMaintenance therapyBayesian designKIT +
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.