Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-02 @ 5:02 AM
Study NCT ID:
NCT00051532
Status:
TERMINATED
Last Update Posted:
2025-02-25
First Post:
2003-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C078903', 'term': 'seocalcitol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'OTHER'}, 'enrollmentInfo': {'count': 700}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-04', 'completionDateStruct': {'date': '2004-05'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2003-01-13', 'studyFirstSubmitQcDate': '2003-01-13', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival, defined as the time from start of treatment to death'}], 'secondaryOutcomes': [{'measure': 'HCC-specific survival from start of treatment'}, {'measure': 'Time to response from start of treatment (complete or partial response)'}, {'measure': 'Proportion of patients who achieve partial/complete response'}, {'measure': 'Time to progression measured from start of treatment'}, {'measure': 'Duration of complete response in patients showing a complete response, measured from the first date when absence of disease was recorded until the first date of disease progression was recorded'}, {'measure': 'Duration of partial response in patients showing partial response, measured from first date when partial response was recorded until the first date at which disease progression was observed'}, {'measure': 'Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed'}, {'measure': 'Change(s) in tumour size'}, {'measure': 'Change in tumour marker'}, {'measure': 'Number of days of hospitalisation (in-patient care)'}, {'measure': 'Quality of life'}, {'measure': 'Adverse events'}, {'measure': 'Change in laboratory values'}, {'measure': 'Dose of seocalcitol (seocalcitol treated patients)'}]}, 'conditionsModule': {'keywords': ['hepatocellular', 'carcinoma', 'liver', 'cancer'], 'conditions': ['Liver Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma \\[HCC\\]).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospital in- or out-patients\n* Either sex\n* Aged 18-75 years\n* With hepatocellular carcinoma, verified by histology/cytology, which is not amenable to curative treatment or transplantation.\n* Patients must have measurable disease, and be classifiable as to Barcelona Clinic Liver Cancer (BCLC) stage 0, as described in Llovet JM et al. Hepatology 1999;29:62-67.\n\nExclusion Criteria:\n\n* Patients treated with chemotherapy or other anti-cancer therapy within 4 weeks before visit 1\n* Patients with another primary tumor, except for basocellular carcinoma of the skin or in situ carcinoma of the cervix, within the last 2 years\n* A history of renal stone(s)\n* A life expectancy of \\< 3 months\n* World Health Organization (WHO) performance status 3 or 4\n* Okuda stage III.\n* Patients with hypercalcemia, or other clinically important laboratory abnormalities\n* Patients with previous/current calcium metabolic disease, taking calcium-lowering therapy, or medication known to affect systemic calcium metabolism are also excluded.\n* All patients must give their signed informed consent to join the study.'}, 'identificationModule': {'nctId': 'NCT00051532', 'briefTitle': 'Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5ug) or Placebo in the Treatment of Patients With Hepatocellular Carcinoma Not Amenable to Curative Treatment', 'orgStudyIdInfo': {'id': 'EBC 9801 INT'}, 'secondaryIdInfos': [{'id': 'EBC 9801 INT'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Seocalcitol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G2C4', 'city': 'Toronto', 'state': 'Alberta', 'country': 'Canada', 'facility': 'E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)'}, {'zip': 'F-57038 Metz Cedex', 'city': 'Metz', 'country': 'France', 'facility': 'E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': 'I-20 122', 'city': 'Milan', 'country': 'Italy', 'facility': 'E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': 'E-08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'EH39YW', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Hanne Hvidberg, MSc Pharm, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LEO Pharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}}}}