Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT00043459
Status:
TERMINATED
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 Previously Treated Patients With Non-Hodgkin's Lymphoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 35}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-07'}, 'statusVerifiedDate': '2003-03', 'completionDateStruct': {'date': '2003-03'}, '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': ['NHL'], 'conditions': ["Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to determine whether T900607-sodium is effective and safe in treating non-Hodgkin's lymphoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Histologically or cytologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL)\n* Subjects must have received prior chemotherapy for their NHL\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* Hemoglobin at least 8.5 g/dL,\n* Creatinine within 2 times upper limit of normal,\n* AST and ALT within 3 times upper limit of normal,\n* Bilirubin within 1.5 times upper limit of normal,\n* Albumin great than 2.5 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 NHL 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"}, 'identificationModule': {'nctId': 'NCT00043459', 'briefTitle': "Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.", 'organization': {'class': 'INDUSTRY', 'fullName': 'Tularik'}, 'orgStudyIdInfo': {'id': 'T-607-007'}}, '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': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College of Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Kerrie Boyd', 'role': 'STUDY_CHAIR', 'affiliation': 'Tularik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tularik', 'class': 'INDUSTRY'}}}}