NCT00267592

Safety and Efficacy of Talampanel in Glioblastoma Multiforme

A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Talampanel	Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.
RADIATION	Radiation Therapy (RT) 5 days a week +
DRUG	temozolomide(TMZ) 75mg	temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks
DRUG	adjuvant TMZ 200mg	adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-09-01
• Completion: 2011-02-01
• First posted: 2005-12-21
• Last updated: 2016-05-19