Calendario›SNY›Aflibercept
Aflibercept
Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma
Ensayo de Sanofi en Pulmonary Diseases · Neoplasms, Lung (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 98
- Centros
- 3
- Fin del objetivo primario
- jul 2008
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en ene 2006.
Qué mide
Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC). (up to 2.5 years from initial treatment) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA). Primary objective: * To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA. Secondary objective: * To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this participant population * To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®). This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00284141), actualizada en nov 2012.