Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-04 @ 5:35 PM
Study NCT ID:
NCT00966251
Status:
TERMINATED
Last Update Posted:
2012-10-23
First Post:
2009-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585832', 'term': 'pidilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'The study was stopped because of slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-22', 'studyFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2009-08-25', 'lastUpdatePostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary Hepatocellular Carcinoma'], 'conditions': ['Primary Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects aged 18 years and above, both genders.\n2. Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)\n3. No fibrolamellar subtype HCC\n4. Not eligible for any other systemic anti-neoplastic treatment approved for HCC\n5. Not eligible for Transarterial chemoembolization (TACE ).\n6. No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA) that were used for HCC, are permitted.\n7. Not a candidate for curative surgical resection or liver transplantation\n8. Measurable disease defined by the identification at least 1 measurable lesion by MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging post-procedure to be considered measurable disease.\n9. Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)\n10. Child's Pugh classification A\n11. ECOG performance status 0-1\n\nExclusion Criteria:\n\n1. Patients progressing to liver failure.\n2. No core biopsy within the past 7 days\n3. Patients who are eligible for Transarterial Chemoembolization (TACE)\n4. Patients on concurrent anti-neoplastic therapy (including interferon)\n5. Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.\n6. Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids\n7. Presence of metastasis."}, 'identificationModule': {'nctId': 'NCT00966251', 'briefTitle': 'Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'CureTech Ltd'}, 'officialTitle': 'Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'CT-2009-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-011', 'interventionNames': ['Drug: CT-011']}], 'interventions': [{'name': 'CT-011', 'type': 'DRUG', 'description': 'CT-011', 'armGroupLabels': ['CT-011']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Yaron Ilan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CureTech Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}