Clinical trial · Interventional
Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment
NCT01694277CI-TRIAL-00048675completedPhase 3ClinicalTrials.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 the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with 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 |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Masitinib
- description
- Participants receive masitinib (12 mg/kg/day), given orally twice daily.
- interventionNames
- Drug: Masitinib
- type
- ACTIVE_COMPARATOR
- label
- Sunitinib
- description
- Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
- interventionNames
- Drug: Sunitinib
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From day of randomization to death, assessed for a maximum of 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main inclusion criteria include: * Patient with histological proven metastatic GIST or non-operable locally advanced GIST * Patient with c-Kit (CD117) positive tumor detected immuno-histochemically * Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment. Main exclusion criteria include: * 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 * Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis * Pregnant, or nursing female patient
References
Publications (0)
Data not yet available
No reference posted for this study.