A Phase 1b study of LDE225 and BKM 120 in advanced solid tumours

• Research type

  Research Study

• Full title

  A Phase 1b multicentre open label dose escalation study of oral LDE225 in combination with BKM120 in patients with advanced solid tumours

• IRAS ID

  105853

• Contact name

  Udai Banerji

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2011-005016-28

• Clinicaltrials.gov Identifier

  NCT01576666

• Research summary

  The purpose of this open label dose Escalation study is to determine a combination maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LDE225 and BKM120 when co-administered orally in patients with advanced solid tumours (specifically, metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic colorectal cancer (CRC) and recurrent glioblastoma multiforme (GBM)).

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/0931

• Date of REC Opinion

  24 Aug 2012

• REC opinion

  Further Information Favourable Opinion