Evaluating Imatinib Treatment After 10 Years for GIST Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Besançon
  Besançon, France Recruiting
• Institut Bergonié
  Bordeaux, France Recruiting
• CHU Dupuytren
  Limoges, France Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting
• CHU de Reims
  Reims, France Recruiting
• Institut Goustave Roussy
  Villejuif, France Recruiting

Study contacts

• Principal investigator: Jean-Yves BLAY, Pr — Centre Léon Bérard, Lyon
• Study coordinator: Jean-Yves BLAY, Pr
• Email: jean-yves.blay@lyon.unicancer.fr
• Phone: +33 4 78 78 27 57

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Velzatinib for advanced GIST after multiple prior TKIs

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• Velzatinib vs. Imatinib as frontline treatment for metastatic or unresectable GIST

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• Imatinib added to artemether-lumefantrine for uncomplicated P. falciparum malaria

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• KQB198 plus imatinib for first-line advanced or metastatic GIST

  This Phase 2 test will see if adding the experimental drug KQB198 to imatinib helps people with advanced or metastatic GIST who are starting first-line treatment.

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• IDRX-42 versus sunitinib for adults with advanced gastrointestinal stromal tumors after imatinib

  This test compares IDRX-42 (GSK6042981) with sunitinib in adults with advanced or unresectable GIST who have already been treated with imatinib to see which controls the cancer better and is safer.

  Recruiting at 156 sites Phase 3 GlaxoSmithKline · Phoenix, Arizona and 155 other locations · NCT07218926

• Imatinib plus fampridine before surgery for KIT exon 11 gastrointestinal stromal tumor

  This trial tests whether adding fampridine to standard imatinib before surgery is safe and helps shrink KIT exon 11 mutant GIST tumors in adults.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.