Calendario›SNY›gemcitabine · ECLIPSE
gemcitabine · ECLIPSE
Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)
Ensayo de Sanofi en Squamous Cell Lung Cancer (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 780
- Centros
- 142
- Fin del objetivo primario
- abr 2013
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2010.
Qué mide
overall survival (del registro, en inglés) (12 meses, 24 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroTo evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01082549), actualizada en feb 2016.