Status:
COMPLETED
Safety and Efficacy of Talampanel in Glioblastoma Multiforme
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients with serious concurrent infection or medical illness.
- Patients receiving concurrent chemotherapeutics or investigational agents.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00267592
Start Date
December 1 2005
End Date
February 1 2011
Last Update
May 19 2016
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