Calendario›SNY›XL765
XL765
A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas
Ensayo de Sanofi en Mixed Gliomas · Malignant Gliomas · Glioblastoma Multiforme (del registro, en inglés).
Más ensayos de: Glioblastoma.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 54
- Centros
- 6
- Fin del objetivo primario
- feb 2012
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 temozolomide in subjects with anaplastic gliomas or glioblastoma currently stable on a maintenance temozolomide dose (Assessed at each visit/periodic visits) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to determine the safety and tolerability of XL765 in combination with Temozolomide in adults with anaplastic gliomas or glioblastoma on a stable Temozolomide maintenance dose. 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. Temozolomide (TMZ, Temodar®) is an orally administered alkylating agent with activity against malignant gliomas. It is approved by the Food and Drug Administration for the following indications: 1) treatment of newly diagnosed glioblastoma multiforme (GBM) patients when given concomitantly with radiotherapy and then as maintenance treatment; 2) refractory anaplastic astrocytoma (AA), ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. Temozolomide is commonly used in the treatment of other anaplastic gliomas (AG) including oligodendroglial tumors and mixed gliomas.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00704080), actualizada en abr 2013.