Clinical trial · Interventional
Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
NCT00998751CI-TRIAL-00036094completedPhase 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 evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic 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 |
|---|---|---|---|
| Gastro-intestinal Stromal Tumours | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral masitinib | Drug | Masitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- masitinib (AB1010)
- description
- oral masitinib 7.5 mg/kg/day
- interventionNames
- Drug: oral masitinib
Primary outcomes (1)
- measure
- Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)
- timeFrame
- 2 months
Secondary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- until disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female patients, age \>18 * Life expectancy \> 6 months * Histological proven, metastatic, or locally advanced and non-operable, non- pre-treated GIST. * Patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy * C-Kit (CD117) positive tumors detected immuno-histochemically * Measurable tumor lesions with longest diameter \>20 mm using conventional techniques or \>10 mm with spiral CT scan Exclusion Criteria: * Documented allergy to the similar drug of AB1010 * Inadequate organ function * Patients with a history of any other malignancy
References
Publications (1)
- RESULTLe Cesne A, Blay JY, Bui BN, Bouche O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, Moussy A, Kinet JP, Hermine O. Phase II study of oral masitinib mesilate in imatinib-naive patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. doi: 10.1016/j.ejca.2010.02.014. Epub 2010 Mar 6. PMID 20211560