specify
Member rating: No Rating | Words: | Submitted: Mon Sep 24 2007
On the left is an image preview of every page of this document, and below are the first 150 words with formatting removed:
A phase II, multi-centre, open -label, Parallel Group, Randomised study to compare the efficacy of X vs Temozolomide in patients with unresectable AJCC stage 3 or 4 Malignant Melanoma. Study Objectives Primary Objective The primary objective of this study is to compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by evaluation of: * The primary outcome variable; progression free survival * The secondary outcome variable; Time to death, objective response rate based on RECIST and duration of response. Secondary Objectives The seconday objectives of the studtyare: * To assess safety and tolerability of X in patients by assessment of AEs , clinical chemistry , haematology, urinalysis, vital sign , echocardiogram and electrocardiogram. * To investigate the PK of X and N-desmethyl X following BD dosing by derivation of PK parameters, which may include Cmax AUC and t1/2 Study design This is a phase II, open-label, multi-centre, randomised...

