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Table 1 Key study objectives

From: Study design and rationale for a randomised, placebo-controlled, double-blind study to assess the efficacy of selumetinib (AZD6244; ARRY-142886) in combination with dacarbazine in patients with metastatic uveal melanoma (SUMIT)

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

  1. AE adverse event, EORTC-QLQC30 v3 European Organisation for Research and Treatment of Cancer 30-item core quality of life questionnaire version 3, GNAQ guanidine nucleotide binding protein (G protein), Q polypeptide 1, GNA11 G protein alpha 11, HRQoL health-related quality of life