IMATINIB MESILATE for Gastrointestinal stromal tumor (advanced/metastatic)

Inclusion criteria

• {"criterion_text":"- I1. Patients ≥ 18 years of age;\n- I2. Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;\n- I3. ECOG Performance status (PS) 0, 1, 2;\n- 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;\n- I5. Patient with controlled disease (without any progression under imatinib);\n- I6. Ability to understand and willingness for follow-up visits;\n- I7. Covered by a medical insurance;\n- I8. Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment."}

Exclusion criteria

• {"criterion_text":"- NI1. Patient concurrently using other approved or investigational antineoplastic agents;\n- NI10. Patient requiring tutorship or curatorship or patient deprivied of liberty.\n- NI2. Patient with GIST harboring the mutation D842V in PDGFRA ;\n- 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;\n- 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;\n- NI5. Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications;\n- NI6. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;\n- NI7. Major surgery within 2 weeks prior to study entry;\n- NI8. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;\n- NI9. Pregnant or breastfeeding women;"}

Primary endpoints

• {"endpoint_text":"- The progression-free rate at 6 months (PFR-6m) expressed in each arm by the rate of patients with a non-progression disease 6 months after randomization.","definition_or_measurement_approach":"Expressed by the rate of patients with non-progression at 6 months after randomization in each arm."}

Secondary endpoints

• {"endpoint_text":"- PFS will be defined as the time from the date of randomization to the date of the first documented progression, or date of death due to any cause. Patients with no event at the time of the analysis will be censored at the date of last available tumor assessment.","definition_or_measurement_approach":"Time from randomization to first documented progression or death; censor at date of last available tumor assessment if no event."}
• {"endpoint_text":"- OS will be defined as the time from the date of randomization to the date of death due to any cause.","definition_or_measurement_approach":"Time from randomization to death from any cause."}
• {"endpoint_text":"- The safety will be determined through the incidence of treatment emergent adverse events (TEAE), serious adverse Events (SAE) and death. Tolerance will be assessed using the NCI-CTC AE v5 grading scale.","definition_or_measurement_approach":"Incidence of TEAEs, SAEs and deaths; graded per NCI-CTCAE v5."}
• {"endpoint_text":"- QoL will be assessed using the EORTC QLQ-C30 questionnaire.","definition_or_measurement_approach":"Quality of life measured by EORTC QLQ-C30 questionnaire scores."}
• {"endpoint_text":"- PFS rechallenge will be defined as the time from the date of imatinib reintroduction in the experimental arm to the date of subsequent progression, or date of death due to any cause. Patients with no event at the time of the analysis will be censored at the the date of last available tumor assessment.","definition_or_measurement_approach":"Time from imatinib reintroduction to subsequent progression or death; censor at last tumor assessment if no event."}
• {"endpoint_text":"- ORR after imatinib reintroduction will be defined as the proportion of patients with a best overall response of Partial Response (PR) or Complete Response (CR) after imatinib reintroduction","definition_or_measurement_approach":"Proportion of patients achieving PR or CR following imatinib reintroduction."}
• {"endpoint_text":"- The duration of response to imatinib after reintroduction will be defined as the time from the date of first objective response following the reintroduction of imatinib to the date of the first subsequent documented radiological progression or death and censored at the date of last available tumor assessment.","definition_or_measurement_approach":"Time from first objective response after reintroduction to documented progression or death; censor at last tumor assessment."}

France

Earliest CTIS Part Ii Submission Date

22-04-2024

Latest Decision Or Authorization Date

27-08-2024

Processing Time Days

127

Number Of Sites

8

Number Of Participants

50

Primary sponsor

Full Name

Centre Leon Berard

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France