GSK2256098 + Trametinib dose escalation study

• Research type

  Research Study

• Full title

  A Phase 1b, multi-center, open-label, dose escalation study of GSK2256098 (FAK inhibitor) in combination with Trametinib (MEK inhibitor) in subjects with advanced solid tumors

• IRAS ID

  136417

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2013-000784-85

• Research summary

  Malignant mesothelioma is a form of cancer that develops from the cells of the mesothelium (the protective lining that covers many of the body’s internal organs such as the lungs, chest and heart). There is currently no widely approved regimen for treating this disease and patients have a median survival time of 12.1 months so a need for more effective therapies is required.

  This study is a Phase 1b, multi-center, open-label, dose escalation study of GSK2256098 (FAK inhibitor) in combination with Trametinib (MEK inhibitor) in patients with advanced solid tumours.

  This study has two parts; the first part of this study is to determine the maximum tolerated dose (MTD) combination and determine the phase 2 dose combination of GSK 2256098 with trametinib in patients with measurable tumors that may benefit from treatment with the drug combination.

  The second part of this study will be the expansion part of the study which will assess the long term safety of the GSK2256098/trametinib combination in patients with malignant pleural mesothelioma

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  13/NW/0634

• Date of REC Opinion

  15 Oct 2013

• REC opinion

  Further Information Favourable Opinion