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Iniparib

A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors

Ensayo de Sanofi en Neoplasm Malignant (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

59

previstos

Centros

6

Fin del objetivo primario

may 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2011.

Qué mide

Assessment of iniparib as single agent and in combination with chemotherapeutic agents related dose limiting toxicities (DLTs) observed at first cycle (3 - 4 weeks) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: * To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent and in combination with chemotherapeutic regimens in patients with advanced solid tumors that are refractory to standard therapy. Secondary Objectives: * To assess the antitumor effect of iniparib (per Response Evaluation Criteria in Solid Tumors \[RECIST\]) Version 1.1 in patients with measurable disease. * To characterize iniparib (and its metabolites, if possible) pharmacokinetics. Based on data generated by 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 (NCT01455532), actualizada en oct 2014.