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VELOUR
Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
Ensayo de Sanofi en Colorectal Neoplasms · Neoplasm Metastasis (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 1.226
- Centros
- 221
- Fin del objetivo primario
- feb 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en nov 2007.
Qué mide
Overall Survival (OS) (From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.
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Ficha completa en ClinicalTrials.gov (NCT00561470), actualizada en sep 2012.