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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00267592 |
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Date of registration:
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19/12/2005 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Talampanel in Glioblastoma Multiforme
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Scientific title:
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A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00267592 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glioblastoma Multiforme
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Intervention(s)
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Drug: Talampanel
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Primary Outcome(s)
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Overall Survival
[Time Frame: 24 months]
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Secondary Outcome(s)
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Talampanel-related toxicity
[Time Frame: 29 months]
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Secondary ID(s)
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IXR-207-21-189 / NABTT 0304
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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