Primary objective | Exploratory objectives |
• Progression-free survival | • Overall survival adjusting for the impact of treatment options available post-progression |
Secondary objectives | • Symptoms and HRQoL using the EORTC-QLQC30 v3 |
• Objective response rate | • Hospital-related resource use and health state utility |
• Duration of response | • Pharmacokinetics versus clinical outcomes, efficacy, AEs and/or safety parameters |
• Change in tumour size at Week 6 | • Explore MEK pathway mutations in GNAQ and GNA11 |
• Overall survival | • Biomarkers for response or development of cancer |
• Safety and tolerability profile | • Host genetic polymorphisms |