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Aflibercept · VANILLA
Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
Ensayo de Sanofi en Pancreatic Neoplasm (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 546
- Centros
- 24
- Fin del objetivo primario
- oct 2009
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en dic 2007.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Data Monitoring Committee concluded after a planned interim analysis that aflibercept added to gemcitabine would be unable to demonstrate improved survival».
Qué mide
Overall Survival (OS) (From the first randomization until the end of study data cutoff date (approximately 2 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 treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine. The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine). The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.
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Ficha completa en ClinicalTrials.gov (NCT00574275), actualizada en may 2016.