NCT01285414

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

A Phase 2 Study of Verubulin With Radiation Therapy and Temozolomide in Subjects Newly Diagnosed With Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Myrexis Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This, international, multi-center, Phase 2 study of verubulin will be conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). 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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Verubulin	Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide \& Radiation Therapy
DRUG	Temozolomide & Radiation Therapy	Temozolomide \& Radiation Therapy

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-01-28
• Last updated: 2012-04-11

Locations

2 sites across 1 country: United States