Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-03 @ 7:46 AM
Study NCT ID:
NCT00267592
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2005-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Talampanel in Glioblastoma Multiforme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C085266', 'term': 'talampanel'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2011-08-16', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2005-12-19', 'dispFirstSubmitQcDate': '2011-08-16', 'studyFirstSubmitQcDate': '2005-12-20', 'dispFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Talampanel-related toxicity', 'timeFrame': '29 months'}]}, 'conditionsModule': {'conditions': ['Glioblastoma Multiforme']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be 18 years of age\n* Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)\n* 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.\n* 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.\n* Patients must have a Karnofsky performance of at least 60% or more.\n\nExclusion Criteria:\n\n* Patients with serious concurrent infection or medical illness.\n* Patients receiving concurrent chemotherapeutics or investigational agents.'}, 'identificationModule': {'nctId': 'NCT00267592', 'briefTitle': 'Safety and Efficacy of Talampanel in Glioblastoma Multiforme', 'nctIdAliases': ['NCT00082992'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme', 'orgStudyIdInfo': {'id': 'IXR-207-21-189 / NABTT 0304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'enzyme-inducing antiseizure drug', 'description': '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.', 'interventionNames': ['Drug: Talampanel', 'Radiation: Radiation Therapy (RT) 5 days a week +', 'Drug: temozolomide(TMZ) 75mg', 'Drug: adjuvant TMZ 200mg']}], 'interventions': [{'name': 'Talampanel', 'type': 'DRUG', 'description': 'Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.', 'armGroupLabels': ['enzyme-inducing antiseizure drug']}, {'name': 'Radiation Therapy (RT) 5 days a week +', 'type': 'RADIATION', 'armGroupLabels': ['enzyme-inducing antiseizure drug']}, {'name': 'temozolomide(TMZ) 75mg', 'type': 'DRUG', 'description': 'temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks', 'armGroupLabels': ['enzyme-inducing antiseizure drug']}, {'name': 'adjuvant TMZ 200mg', 'type': 'DRUG', 'description': 'adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.', 'armGroupLabels': ['enzyme-inducing antiseizure drug']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}