Calendario›SNY›INIPARIB + irinotecan

INIPARIB + irinotecan

A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

Ensayo de Sanofi en Estrogen Receptor Negative (ER-Negative) Breast Cancer · Progesterone Receptor Negative (PR-Negative) Breast Cancer · Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer · Brain Metastases (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

44

previstos

Centros

13

Fin del objetivo primario

oct 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jul 2010.

Qué mide

Efficacy (del registro, en inglés) (12 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan. 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 (NCT01173497), actualizada en feb 2016.