Clinical trial · Interventional
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumor in First Line Medical Treatment
NCT00812240CI-TRIAL-00063603terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision based on portfolio prioritization
Summary
Brief summary (as posted)
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
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 (4)
- type
- EXPERIMENTAL
- label
- Masitinib (7.5)
- description
- Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
- interventionNames
- Drug: Masitinib
- type
- EXPERIMENTAL
- label
- Masitinib (6.0)
- description
- Participants receive masitinib (6.0 mg/kg/day), given orally twice daily
- interventionNames
- Drug: Masitinib
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator (7.5)
- description
- Participants receive imatinib at 400 or 600 mg per day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main inclusion criteria include: * Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST * Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation * c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative Main exclusion criteria include: * Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria * 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
References
Publications (0)
Data not yet available
No reference posted for this study.