A prospective, multicenter, randomized, open-label, active-controlled, 2-parallel group, phase III study to compare efficacy and safety of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment
- Conditions
- gastro-intestinal stromal tumourMedDRA version: 9.1 Level: LLT Classification code 10051066 Term: Gastrointestinal stromal tumour
- Registration Number
- EUCTR2008-000973-40-FR
- Lead Sponsor
- AB SCIENCE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 222
1.Histologically proven, metastatic or locally advanced non resectable, or recurrent post surgery GIST
2.Patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
3.Measurable tumour lesions with longest diameter = 20 mm using conventional techniques or = 10 mm with spiral CT scan according RECIST criteria
4.C-Kit (CD117) positive tumours detected immuno-histochemically or PDGF positive if c-kit negative
5.ECOG < 1
6.Patient with adequate organ function:
•absolute neutrophil count (ANC) = 1.5 x 109/L
•Haemoglobin = 10 g/dL
•platelets (PTL) = 100 x 109/L
•AST/ALT = 2.5x ULN (= 5 x ULN in case of liver metastases)
•bilirubin = 1.5x ULN
•creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
•albumin > 0.75 x LLN
•urea = 1.5 x ULN
•proteinuria < 30 mg/dL on the dipstick; in case of proteinuria = 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours
7.Patient with life expectancy > 6 months
8.Men or women, age >18 years
9.Men and women of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) 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.
10.Patient should be able and willing to comply with study procedures as per protocol.
11.Patient should be able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria 2
2.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
3.Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
4.Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline)
5.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
6.Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events
?Previous treatment
7.Treatment with any investigational agent within 4 weeks prior baseline
8.Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method