The objective is to compare the efficacy and safety of masitinib 12 mg/kg/day to sinutinib 50 mg/day
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall survival
Secondary outcome
- time to treatment failure,
- overall progression free survival rate at weeks 8, 16, 24 and then every 12
weeks
- survival rate at weeks 8, 16, 24 and the every 12 weeks
- overall time to progression
- time to progression rate at weeks 8, 16, 24 and then every 12 weeks
- best response
- best response rate
- objective response
- objective response rate
- disease control
disease control rate at weeks 8, 16, 24 and then every 12 weeks
Background summary
protocol version 8, 15 december 2014: p37 - p62
Study objective
The objective is to compare the efficacy and safety of masitinib 12 mg/kg/day
to sinutinib 50 mg/day
Study design
prospective, multicenter, randomised, open-label, active-controlled,
two-parallel groups, phase 3 study.
Intervention
- 175 patients will be treated with masitinib 12 mg/kg/day
- 175 patients will be treated with sinutinib 50 mg/day
Study burden and risks
Not applicable
Alfons Smetsplein 3H1
Leuven 3000
BE
Alfons Smetsplein 3H1
Leuven 3000
BE
Listed location countries
Age
Inclusion criteria
1. patient with histological proven metastatic GIST (gastro-intestinal stromal cancer) 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 tuimour detected immunohistochemically;
4. patient after progression with imatinib up to 800mg;
5. patient with ECOG <=2;
6.Patient with adequate organ functions;
7. patient with life expectancy >3 months;
8. male or female >18 years;
9. patient with a BMI > 18 kg/m2 and weightening at least 40 kg;
Exclusion criteria
1. patient treated for a cancer other vthan GIST within 5 years before enrolmentwith the exception of basal cell carcinoma or cervical cancer in situ;
2. patient with active CNS metastasis or with history of CNS mtastasis;
3. patient with certain cardiac disorder;
4.patient with history of poor compliance or history of drug/alcohol abuse or excessive alcohol beverage consumption;
5. pregnant or nursing female
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 0069-0550-38 |
EudraCT | EUCTR2011-001790-41-NL |
CCMO | NL41704.078.12 |