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XL765

Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors

Ensayo de Sanofi en Cancer de pulmon no microcitico.

Más ensayos de: Cáncer · Cáncer de pulmón no microcítico.

Fase

Fase 1

Estado

Completado

Participantes

80

previstos

Centros

1

Fin del objetivo primario

feb 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ago 2008.

Qué mide

Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib (Assessed during periodic visits) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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Ficha completa en ClinicalTrials.gov (NCT00777699), actualizada en feb 2012.