This study aims to compare the efficienty and safety of masitinib at a dose of 12 mg/kg/dag to those of a standard treatment for GIST: sunitinib (Sutent) at a dose of 50 mg/day for 4 consecutive weeks followed by 2 weeks without medication. Masitinib and sunitinib will be administred untill disease progression in patients with GIST resitant to imatinib (Glivec)
- Conditions
- stromal gastrointestinal cancer (GIST)MedDRA version: 18.0Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001790-41-BE
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 208
1.Patient with histological proven metastatic GIST or non-operable locally advanced GIST
2.Patient with measurable tumor lesions with longest diameter = 20 mm using conventional techniques or = 10 mm with spiral CT scan according to RECIST 1.1
3.Patient with C-kit (CD117) positive tumour detected immuno-histochemically
4.Patient after at least one progression with imatinib at at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment.
5.Patient with ECOG = 2
6.Patient with adequate organ functions:
•Absolute neutrophils count (ANC) = 1.5 x 109/L
•Haemoglobin = 10 g/dL
•Platelets (PTL) = 75 x 109/L
•AST/ALT = 3x ULN (= 5 x ULN in case of liver metastases)
•Gamma GT = 2.5 x ULN (= 5 x ULN in case of liver metastases)
•Bilirubin = 1.5x ULN (= 3xULN in case of liver metastases)
•Normal Creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
•Albumin > 1 x LLN
•Proteinuria < 30 mg/mL (1+) on the dipstick. If proteinuria is = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
7.Patient with life expectancy > 6 months
8.Male or female patient, age >18 years
9.Patient BMI > 18 kg/m² and weight > 40 kg
10.Male and female patient of child bearing potential must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. Female paitent of child bearing potential must have a negative pregnancy test at screening and baseline.
11.Patient able and willing to comply with study procedures as per protocol
12.Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
13.Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment
14.Patient covered by insurance reimbursing sunitinib
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 208
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
2.Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
3.Patient presenting with cardiac disorders defined by at least one of the following conditions:
•Patient with recent cardiac history (within 6 months) of:
-Acute coronary syndrome
-Acute heart failure (class III or IV of the NYHA classification)
-Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
•Patient with cardiac failure class III or IV of the NYHA classification
•Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
•Syncope without known aetiology within 3 months
•Uncontrolled severe hypertension, according ot the judgement of the investigator, or symptomatic hypertension
4.Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
5.Pregnant, or nursing female patient
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective: the efficacy of masitinib 12 mg/kg/day in comparison with sunitinib 50 mg/day in patients with stromal gastrintestinal cancer previously progressed after treatment with imatinib;Secondary Objective: Secondary objectives: safety and quality of life;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: week 24
- Secondary Outcome Measures
Name Time Method