iniparib

An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer

Ensayo de Sanofi en Cancer de mama.

Fase: no aplica
Estado: Ya no disponible

Qué significa cada fase y cada estado.

Estudio de acceso ampliado.

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe following trial is designed to offer pre-approval drug access to iniparib in combination with gemcitabine and carboplatin in order to provide potential clinical benefit to patients with ER-, PR-, and HER2-negative metastatic breast cancer. This follows an ongoing Phase 3, multi-center, open-label, randomized study of gemcitabine/carboplatin, with or without iniparib, in patients with ER-, PR-, and HER2-negative metastatic breast cancer (protocol 20090301). 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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Ficha completa en ClinicalTrials.gov (NCT01130259), actualizada en sep 2013.