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XL147

Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma

Ensayo de Sanofi en Endometrial Cancer · Endometrial Neoplasms (del registro, en inglés).

Más ensayos de: Cáncer de endometrio.

Fase

Fase 2

Estado

Completado

Participantes

67

previstos

Centros

13

Fin del objetivo primario

mar 2013

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Efficacy as defined by overall response rate and progression-free survival (PFS) at 6 months (every 8-10 weeks) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThere has not been any systemic therapy approved in the United States or in Europe for treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety and preliminary efficacy of XL147 in advanced or recurrent EC. Constitutively active phosphatidylinositol-3 kinase (PI3K)/phosphatase and tensin homolog on chromosome 10 (PTEN) pathway signaling is common in EC and involved in the development and/or progression of the disease. PTEN deficiency and/or activating mutations/amplification in the PIK3CA gene that encodes the p110α catalytic subunit of PI3K have been frequently detected in EC patients. XL147 is a potent and highly selective inhibitor of the Class I PI3K family of lipid kinases. In addition, in vivo preclinical data have demonstrated that XL147 targets both proximal and distal signaling in the PI3K/PTEN pathway. Therefore, XL147 may have utility in the treatment of subjects with advanced or recurrent EC.

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Ficha completa en ClinicalTrials.gov (NCT01013324), actualizada en may 2016.