Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT01251458
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2010-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hepatocellular Carcinoma (HCC)_Torisel_
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C401859', 'term': 'temsirolimus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2010-12-01', 'studyFirstSubmitQcDate': '2010-12-01', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC)', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': '• To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC', 'timeFrame': '2 Years'}, {'measure': '• To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel®', 'timeFrame': '4 Years'}, {'measure': '• To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel®', 'timeFrame': '2 years'}, {'measure': '• To determine the response rate (CR and PR) based on RECIST criteria', 'timeFrame': '2 years'}, {'measure': '• To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks)', 'timeFrame': '2 years'}, {'measure': '• To determine duration of response (DR)', 'timeFrame': '2 years'}, {'measure': '• To determine overall survival (OS)', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inoperable HCC']}, 'descriptionModule': {'briefSummary': 'This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection\n* measurable disease\n* Age \\>=18 years.\n* Life expectancy of greater than 12 weeks.\n* ECOG performance status \\<= 2\n* Prior systemic therapy for HCC is allowed\n* Adequate haematologic, renal and hepatic function\n* Absence of cirrhosis or Child's A cirrhosis\n* Fasting total cholesterol \\<9.1 mmol/liter and fasting triglyceride level \\<4.5 mmol/liter)\n\nExclusion Criteria:\n\n* Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.\n* Patients receiving any other investigational agents concurrently.\n* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant women."}, 'identificationModule': {'nctId': 'NCT01251458', 'briefTitle': 'Hepatocellular Carcinoma (HCC)_Torisel_', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Phase I/II Study of Temsirolimus (Torisel®) as Novel Therapeutic Drug for Patients With Unresectable Hepatocellular Carcinoma (HCC)- A Correlative Study With Stathmin Over-expression', 'orgStudyIdInfo': {'id': 'HCC022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Torisel', 'interventionNames': ['Drug: Torisel']}], 'interventions': [{'name': 'Torisel', 'type': 'DRUG', 'description': 'Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.', 'armGroupLabels': ['Torisel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Clinical Oncology, Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Winnie Yeo, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Oncology, The Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Comprehensive Clinical Trial Unit', 'investigatorFullName': 'CCTU', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}