Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT00033202
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2002-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C433984', 'term': 'ST 1481'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-02', 'studyFirstSubmitDate': '2002-04-09', 'studyFirstSubmitQcDate': '2002-04-09', 'lastUpdatePostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Solid Tumor', 'Camptothecin', 'Pharmacokinetics'], 'conditions': ['Solid Malignancies']}, '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, 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/cytologically proven advanced solid tumors\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': 'NCT00033202', 'briefTitle': 'This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sigma-Tau Research, Inc.'}, 'officialTitle': 'Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.', 'orgStudyIdInfo': {'id': 'ST 01-401'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gimatecan® (ST-1481)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'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'}, {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}]}}}