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Safety and Efficacy of Talampanel in Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00267592
Recruitment Status : Completed
First Posted : December 21, 2005
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE December 19, 2005
First Posted Date  ICMJE December 21, 2005
Last Update Posted Date May 19, 2016
Study Start Date  ICMJE December 2005
Actual 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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
Talampanel-related toxicity [ Time Frame: 29 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Talampanel
  • Radiation: Radiation Therapy (RT) 5 days a week +
  • Drug: temozolomide(TMZ) 75mg
  • Drug: adjuvant TMZ 200mg
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
Actual Enrollment  ICMJE
 (submitted: December 20, 2005)
72
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00267592
Other Study ID Numbers  ICMJE IXR-207-21-189 / NABTT 0304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teva Pharmaceutical Industries
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP