gastro-intestinal stromal tumour MedDRA version: 9.1 Level: LLT Classification code 10051066 Term: Gastrointestinal stromal tumour
Conditions
Interventions
Product Name: AB1010 Tablets
Product Code: AB1010 Tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
Sponsors
AB SCIENCE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 0.75 x LLN • urea = 1.5 x ULN • proteinuria 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to compare the safety and efficacy of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment. ;Primary end point(s): Progression Free Survival (PFS). ; Secondary Objective: ? Tumour assessment: o Overall Survival (OS) o Time to progression (TTP). o Objective response rate (CR + PR) at month 6, 12, 18 and 24 o Control disease rate (CR + PR + SD) at month 6, 12, 18 and 24 o Best response • Association between PFS, OS, TTP, objective response, control disease and the phenotype of mutations on KIT/PDGF • Quality of life assessment: o Quality of Life according to the EORTC QLQ-C30 questionnaire at month 6, 12, 18 and 24 o ECOG Performance Status at month 6, 12, 18 and 24 • Safety o Safety profile using the NCI CTC v3.0 classification | — |
Countries
Austria, Belgium, France, Germany, Greece, Hungary, Netherlands, Spain, United Kingdom
Outcome results
None listed