BridgeMD
Study evaluating the interest of imatinib treatment maintenance or interruption after at least 10 years of treatment in patients with locally Advanced or metastatic Gastrointestinal Stromal Tumors
EU CTIS ID: 2024-512631-77-00
What this study is testing
To compare the 6-month progression-free rate (PFR-6m) between interruption versus maintenance of imatinib treatment in patients with an advanced/metastatic GIST controlled after 10 years of imatinib treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- I1. Patients ≥ 18 years of age;
- I2. Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;
- I3. ECOG Performance status (PS) 0, 1, 2;
- I4. 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;
- I5. Patient with controlled disease (without any progression under imatinib);
- I6. Ability to understand and willingness for follow-up visits;
You likely can't join if
- NI1. Patient concurrently using other approved or investigational antineoplastic agents;
- NI10. Patient requiring tutorship or curatorship or patient deprivied of liberty.
- NI2. Patient with GIST harboring the mutation D842V in PDGFRA ;
- NI3. 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;
- NI4. 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) or patient without residual disease for at least 3 years;
- NI5. Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications;
See the full eligibility criteria
- I1. Patients ≥ 18 years of age;
- I2. Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;
- I3. ECOG Performance status (PS) 0, 1, 2;
- I4. 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;
- I5. Patient with controlled disease (without any progression under imatinib);
- I6. Ability to understand and willingness for follow-up visits;
- I7. Covered by a medical insurance;
- I8. Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
- NI1. Patient concurrently using other approved or investigational antineoplastic agents;
- NI10. Patient requiring tutorship or curatorship or patient deprivied of liberty.
- NI2. Patient with GIST harboring the mutation D842V in PDGFRA ;
- NI3. 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;
- NI4. 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) or patient without residual disease for at least 3 years;
- NI5. Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications;
- NI6. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;
- NI7. Major surgery within 2 weeks prior to study entry;
- NI8. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;
- NI9. Pregnant or breastfeeding women;
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.