Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 11:22 AM
Study NCT ID:
NCT00043433
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2002-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-07'}, 'statusVerifiedDate': '2004-04', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2002-08-08', 'studyFirstSubmitQcDate': '2002-08-09', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HCC'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Histologically or cytologically confirmed diagnosis of HCC\n* Child-Pugh liver classification of A or B\n* Subjects must not have received prior chemotherapy or radiotherapy for their HCC\n* At least 18 years of age\n* Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.\n* Karnofsky performance status of at least 70%\n* Estimated life expectancy of at least 12 weeks\n* Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive\n* Subject must be able to comply with study procedures and follow-up examinations.\n* Signed written informed consent\n* Lab Values (obtained ≤ 7 days prior to study enrollment):\n* ANC at least 1.5x10e9/L,\n* Platelet count at least 100x10e9/L,\n* Creatinine within 2 times upper limit of normal\n* AST and ALT within 5 times upper limit of normal\n* Bilirubin within 1.5 times upper limit of normal\n* Albumin great than 2.8 g/dL\n\nExclusion Criteria\n\n* Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment\n* NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of \\<50%, or acute anginal symptoms\n* Patients who have received any investigational agent within 4 weeks of enrollment\n* Patients who are pregnant or breast-feeding\n* History of prior malignancy other than cancer studied within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* History of central nervous system metastases or carcinomatous meningitis\n* Major surgery within 4 weeks of enrollment\n* Patients who have received prior chemotherapy, chemoembolization, immunotherapy, or radiotherapy for their HCC. Prior surgical resection, intratumoral ethanol injection, hormonal therapy, cryosurgery, radiofrequency ablation, selective internal radiation or embolization, is permitted ONLY if \\> 6 weeks has passed since therapy and there is an indicator lesion (\\> 1 x 1 cm) outside the area of prior treatment (recurrence at the margin or resection is allowed)'}, 'identificationModule': {'nctId': 'NCT00043433', 'briefTitle': 'Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tularik'}, 'orgStudyIdInfo': {'id': 'T-607-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intravenous T900607-sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Health Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ellis Fischel Cancer Center', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Charlene Sum', 'role': 'STUDY_CHAIR', 'affiliation': 'Tularik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tularik', 'class': 'INDUSTRY'}}}}