Safety and Efficacy of Talampanel in Glioblastoma Multiforme

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00267592

First received: December 19, 2005

Last updated: March 19, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 19, 2005
Last Updated Date	March 19, 2013
Start Date ^ICMJE	December 2005
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 3, 2010)	Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00267592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 18, 2011)	Talampanel-related toxicity [ Time Frame: 29 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Talampanel in Glioblastoma Multiforme
Official Title ^ICMJE	A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Glioblastoma Multiforme
Intervention ^ICMJE	Drug: Talampanel Radiation Therapy (RT) 5 days a week + temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks. One month later, adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months. Talampanel was administered orally TID beginning the first day of RT + TMZ and continued until there was talampanel-related toxicity or tumor progression.
Study Arm (s)	Experimental: enzyme-inducing antiseizure drug 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. Intervention: Drug: Talampanel
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	72
Completion Date	February 2011
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00267592
Other Study ID Numbers ^ICMJE	IXR-207-21-189 / NABTT 0304
Has Data Monitoring Committee	Not Provided
Responsible Party	Teva Pharmaceutical Industries
Study Sponsor ^ICMJE	Teva Pharmaceutical Industries
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Teva Pharmaceutical Industries
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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