Clinical trial · Interventional
Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib
NCT01506336CI-TRIAL-00036089completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastro Intestinal Stromal Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- masitinib
- description
- masitinib 12 mg/kg/day
- interventionNames
- Drug: masitinib
- type
- ACTIVE_COMPARATOR
- label
- sunitinib
- description
- sunitinib 50 mg/day
- interventionNames
- Drug: sunitinib
Primary outcomes (1)
- measure
- overall progression free survival
- timeFrame
- up to 36 weeks
- description
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological proven, metastatic, or locally advanced and non-operable GIST 2. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria 3. C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available 4. Patients resistant to imatinib at dose of 400 mg/day Exclusion Criteria: 1. Patient treated for a cancer other than GIST cancer 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
References
Publications (1)
- RESULTAdenis A, Blay JY, Bui-Nguyen B, Bouche O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blesius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial. Ann Oncol. 2014 Sep;25(9):1762-1769. doi: 10.1093/annonc/mdu237. Epub 2014 Jul 25. PMID 25122671