Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT00032903
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2002-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'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': 'C433984', 'term': 'ST 1481'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-02', 'studyFirstSubmitDate': '2002-04-05', 'studyFirstSubmitQcDate': '2002-04-05', 'lastUpdatePostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Malignant Glioma, Camptothecin, Pharmacokinetics'], 'conditions': ['Malignant Glioma']}, 'descriptionModule': {'briefSummary': "Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Histologically confirmed diagnosis of a recurrent primary malignant glioma\n* Life expectancy of at least 3 months with normal hematological, liver and renal function\n\nExclusion criteria:\n\n* Pregnant and lactating patients\n* Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy\n* Gastrointestinal dysfunction that could alter absorption or motility'}, 'identificationModule': {'nctId': 'NCT00032903', 'briefTitle': 'This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sigma-Tau Research, Inc.'}, 'officialTitle': 'Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial', 'orgStudyIdInfo': {'id': 'ST 01-402'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gimatecan® (ST 1481)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sigma-Tau Research, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Rhode Island Hospital', 'class': 'OTHER'}]}}}