Home Information for Clinicians Objectives and Endpoints

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Objectives and Endpoints PDF Print
This "Information for Clinicians" section of the Azixa™ (verubulin, MPC‑6827) GBM Clinical Trials website is intended primarily for the use of healthcare professionals.

Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme (NCT01285414)

Purpose:

The study will be conducted in two parts. Part A is an open-label dose finding study that will determine the safety and tolerability of verubulin in combination with standard treatment. Part B is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving verubulin, at the dose determined in Part A, in combination with standard treatment versus standard treatment alone.

Study Design:

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measures:

Part A: Safety
Part B: To determine progression-free survival rate at nine months

Secondary Outcome Measures:

Part A: Pharmacokinetics
Part B: To determine progression free survival at six and 12 months
Overall Survival


MPC-6827 for Recurrent Glioblastoma Multiforme (NCT00892931)

Purpose:

The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme

Study Design:

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measures:

To determine the rate of progression-free survival at six months

Secondary Outcome Measures:

Overall response rate with a maximum of 18-months follow-up
Overall survival