Safety and Efficacy of Talampanel in Glioblastoma Multiforme

Phase 2

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Talampanel; Radiation: Radiation Therapy (RT) 5 days a week +; Drug: temozolomide(TMZ) 75mg; Drug: adjuvant TMZ 200mg

• Registration Number: NCT00267592
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-19
• Study First Submitted QC: 2005-12-20
• Study First Posted: 2005-12-21
• Primary Completion: 2008-09
• Study Completion: 2011-02
• Disposition First Submitted: 2011-08-16
• Disposition First Submitted QC: 2011-08-16
• Disposition First Posted: 2011-08-23
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patients must be 18 years of age
• Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
• Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
• Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment.
• Patients must have a Karnofsky performance of at least 60% or more.

Exclusion Criteria

• Patients with serious concurrent infection or medical illness.
• Patients receiving concurrent chemotherapeutics or investigational agents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
enzyme-inducing antiseizure drug	Radiation Therapy (RT) 5 days a week +	A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group.
enzyme-inducing antiseizure drug	temozolomide(TMZ) 75mg	A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group.
enzyme-inducing antiseizure drug	adjuvant TMZ 200mg	A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group.
enzyme-inducing antiseizure drug	Talampanel	A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group.

Primary Outcome Measures

Name	Time	Method
Overall Survival	24 months

Secondary Outcome Measures

Name	Time	Method
Talampanel-related toxicity	29 months