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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| masitinib | Experimental | masitinib 12 mg/kg/day |
|
| sunitinib | Active Comparator | sunitinib 50 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| masitinib | Drug | masitinib 12 mg/kg/day |
| |
| sunitinib |
| Measure | Description | Time Frame |
|---|---|---|
| overall progression free survival | 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 | up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | From date of randomization until the date of death from any cause, assessed up to 36 weeks | up to 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Axel Le Cesne, MD | Institut Gustave Roussy, Villejuif, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute Gustave Roussy (IGR) | Villejuif | 94815 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25122671 | Result | Adenis 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. |
| Label | URL |
|---|---|
| Publication of clinical study results | View source |
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| ID | Term |
|---|---|
| C526575 | masitinib |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
sunitinib 50 mg/day |
|
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |