RAD001 in combination with BEZ235 in patients with advanced tumours

• Research type

  Research Study

• Full title

  An open-label, multi-center Phase I dose-finding study of RAD001 (everolimus, Afinitor®) in combination with BEZ235 in patients with advanced solid tumours.

• IRAS ID

  91540

• Contact name

  Elizabeth Ruth Plummer

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-001425-24

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a clinical research study to find out if the drugs RAD001 (Afinitor©) and BEZ235 given in combination are safe and has beneficial effects in people who have advanced solid tumors (in the dose-finding part of the study) and in people who have ERﱱ metastatic breast cancer or metastatic renal cell carcinoma (in the dose expansion part of the study). The initial group in the dose-finding phase will be to assess the safety of the starting doses for RAD001 and BEZ235. More than 13,500 patients have received RAD001 to date, and so far, about 100 patients with different types of tumors have received BEZ235, either alone or in combination with another anti-cancer drug. About 73 patients will join in this study at approximately 12 research centers participating around the world.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  11/NE/0354

• Date of REC Opinion

  25 Jan 2012

• REC opinion

  Further Information Favourable Opinion