This study aims to compare the efficiency and safety of masitinib at a dose of 12 mg/kg/dag to those of a standard treatment for GIST: sunitinib (Sudent) at a dose of 50 mg/day for 4 consecutive weeks followed by weeks without medication. Masitinib and sunitinib will be administred untill disease progression in patients with GIST after receiving standard: imatinib (Glivac)

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2011-001790-41-DE
• Date of registration: 20/11/2012
• Prospective Registration: Yes
• Primary sponsor: AB Science
• Public title: This study aims to compare the efficiency and safety of masitinib at a dose of 12 mg/kg/dag to those of a standard treatment for GIST: sunitinib (Sudent) at a dose of 50 mg/day for 4 consecutive weeks followed by weeks without medication. Masitinib and sunitinib will be administred untill disease progression in patients with GIST after receiving standard: imatinib (Glivac)
• Scientific title: A prospective, multicenter, randomised, open-label, active controlled, 2 parallel groups, phase 3 study to compare the efficay and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imitinib
• Date of first enrolment: 04/06/2013
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001790-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: yes; Other specify the comparator: sunitinib (Sudent); Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, France, Germany, Greece, Italy, Spain, United Kingdom, United States

Contacts

• Name: Urszula BOGUCKA
• Affiliation: AB Science

• Name: Urszula BOGUCKA
• Affiliation: AB Science

Key inclusion & exclusion criteria

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
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

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 350
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
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 CNS metastasis or with history of CNS metastasis
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

MedDRA version: 18.1 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1003 (name of active substance)
Other descriptive name: AB1010 (name of finished product)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
Current Sponsor code: AB1003 (name of active substance)
Other descriptive name: AB1010 (name of finished product)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Sutent
Product Name: Sutent
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunitinib
CAS Number: 341031-54-7
Current Sponsor code: Sunitinib
Other descriptive name: SUNITINIB MALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: Secondary objectives: safety and quality of life

Primary end point(s): Overall survival (OS)

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

Timepoint(s) of evaluation of this end point: week 24

Secondary Outcome(s)

Secondary end point(s): - time to treatment failure
- overall progression free survival (PFS)
- PFS rate at weeks 8, 16, 24 and than every 12 weeks
- survival rate at weeks 8, 16, 24 and than every 12 weeks
- overall time to progression (TTP)
- TTP rate at weeks 8, 16, 24 and then every 12 weeks
- Best Response
- best response rate
- Objective response
- disease control
- disease control rate
- discontinuation for related adverse event (AE)
- discontinuation for related AE rate
- related grade 3 non hematological or any related grade 4 related AE
- safety event free survival
-safety event free survival rate at weeks 8, 16, 24 and then every 12 weeks
- total event free survival rate at week 8, 16, é' and then every 12 weeks
- safety profile using the NCI CTCAE v4.02
- quality of life assessment
- objective response rate

Timepoint(s) of evaluation of this end point: Week 24

Secondary ID(s)

AB11002

2011-001790-41-FR

Source(s) of Monetary Support

AB Science

Ethics review

Status: Approved
Approval date:
Contact: