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A Phase II, single-arm study of orally administered BEZ235 as second-line therapy in patients with advanced endometrial carcinoma

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-024396-12

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Extrait

• To demonstrate the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per RECIST (Novartis guidelines based on RECIST Version 1.1) in patients with advanced endometrial carcinoma who exhibit PI3K pathway activation defined as the presence of a PIK3CA and/or PTEN mutation and/or PTEN negative by IHC (less than 10% staining). • To demonstrate the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per RECIST in all patients enrolled in the study.

Critère d'inclusion

  • Patients who have experienced progression of disease after first-line antineoplasic treatment of advanced endometrial carcinoma

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