locally advanced or metastatic Gastrointestinal Stromal Tumors
Conditions
Interventions
Trade Name: Glivec
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Imatinib
CAS Number: 152459-95-5
Other descriptive name: IMATINIB
Concentration unit: mg milligram(s)
Concentration type: up
Sponsors
Centre Léon Berard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: NI1.Patient concurrently using other approved or investigational antineoplastic agents; 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 or patient without residual disease for at least the last 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; NI10.Patient requiring tutorship or curatorship or patient deprivied of liberty.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To compare between the 2 arms: •the progression free survival (PFS); •the overall survival (OS); •the safety; •the Quality of Life (QoL). In the interruption arm only: To determine in the subgroup of patients who progressed: •the Progression-Free Survival rechallenge (PFS rechallenge); •the Objective Response Rate; •the duration of response (DOR) after imatinib reintroduction; ;Primary end point(s): the progression-free rate at 6 months (PFR-6m) expressed in each arm by the rate of patients with a non-progressive disease 6 months after randomization.;Timepoint(s) of evaluation of this end point: 6 months after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -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. -OS will be defined as the time from the date of randomization to the date of death due to any cause. -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. -QoL will be assessed using the EORTC QLQ-C30 questionnaire. -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. -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 -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. ;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Countries
France
Contacts
Public ContactDRCI
Centre Léon BERARD
Outcome results
None listed