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Safety and Efficacy of Talampanel in Glioblastoma Multiforme

NCT00267592 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-05-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-09-30
Completion
2011-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00267592 on ClinicalTrials.gov