A phase II study of BEZ235 in patients with endometrial carcinoma.

• Research type

  Research Study

• Full title

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

• IRAS ID

  73749

• Contact name

  Rebecca Kristeleit

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Eudract number

  2010-024396-12

• ISRCTN Number

  not known

• Research summary

  This is a prospective multi-centre, open-label, single arm, Phase II study to investigate the safety and efficacy of BEZ235 in patients with advanced endometrial carcinoma whose disease has progressed on or after a first-line anti-neoplastic treatment. Patients will receive a once daily oral dose of 1000 mg BEZ235 until disease progression or until pre-defined discontinuation criteria are met. Tumour assessments by CT scan will be done every 8 weeks until disease progression after which patients will be followed up for survival.About 140 patients will join this study in approximately 70 centres worldwide.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/0359

• Date of REC Opinion

  4 May 2011

• REC opinion

  Further Information Favourable Opinion