A phase 1b study of patients with selected advanced solid tumours

• Research type

  Research Study

• Full title

  A phase 1b open label multicentre dose escalation and expansion study of orally administered MEK162 plus BYL719 in adult patients with selected advanced solid tumours

• IRAS ID

  93652

• Contact name

  Udai Banerji

• Eudract number

  2011-002578-21

• ISRCTN Number

  n/a

• Research summary

  The primary purpose of this open label, dose finding study is to determine the maximum tolerated doses and/or the recommended doses for the expansion phase of orally administered PI3K alpha inhibitor BYL719 in combination with the MEK1/2 inhibitor MEK162. Within the proposed study, the dose escalation part of the study will be conducted in adult patients with advanced RAS (KRAS or NRAS) or BRAF-dependent cancers (with or without PIK3CA mutation or amplification), such as Colorectal cancer, oesophageal cancer, pancreatic cancer, non small cell lung cancer or other advanced solid tumours as agreed by the Sponsor. Pancreatic cancer patients may be enrolled without prior determination of KRAS or BRAF mutation status (for the dose escalation part only) due to the high frequency of KRAS mutations (up to ~90%) observed in this patient population. The trial is designed as a dose-escalation study which means the initial dose given to patients will be low and will only be increased when it has been assessed to be safe. Once the maximum tolerated dose is reached the expansion part of the study will be opened to recruitment. Patients will be treated at a single dose level to further assess the safety and tolerability of BYL719 and MEK162 when given in combination.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/2022

• Date of REC Opinion

  14 Feb 2012

• REC opinion

  Further Information Favourable Opinion