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New treatment option for Metastatic Gastrointestinal Stromal Tumor (GIST)
Official title Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)
ClinicalTrials.gov ID: NCT05009927
What this study is testing
What is Imatinib tablets?
Imatinib tablets is an investigational medicine, being studied as a potential treatment for metastatic gastrointestinal stromal tumor (gist).
Also referred to as Glivec.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 2 arms study concerning patients under imatinib treatment for at least 10 years of treatment with locally advanced/metastatic GIST. In the first arm, patients will discontinue Imatinib treatment.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients ≥18 years of age;
- Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either...
- 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...
- Patient with controlled disease (without any progression under imatinib);
You likely can't join if
- 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...
- 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...
- Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or...
- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Limoges, France
- Lyon, France
- Marseille, France
- Paris, France
- Reims, France
- Rennes, France
- Saint-Herblain, France
- Saint-Paul-en-Jarez, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Limoges, France; Lyon, France; Marseille, France; Paris, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.