Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00291005
Status:
COMPLETED
Last Update Posted:
2009-03-27
First Post:
2006-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'lastUpdateSubmitDate': '2009-03-26', 'studyFirstSubmitDate': '2006-02-10', 'studyFirstSubmitQcDate': '2006-02-10', 'lastUpdatePostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)'}], 'secondaryOutcomes': [{'measure': 'Overall response rate by modified WHO criteria, PSA response rate, safety'}]}, 'conditionsModule': {'keywords': ['Prostate cancer', 'HRPC', 'AIPC', 'Hormone refractory', 'Androgen independent', 'Docetaxel', 'Taxotere', 'prednisolone'], 'conditions': ['Prostatic Neoplasms']}, 'descriptionModule': {'briefSummary': '* To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer\n* To evaluate PSA (tumor marker) response rate\n* To evaluate safety'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.\n\nExclusion Criteria:\n\n* 1.Body temperature \\> 38 degree centigrade.\n* 2.Prior radiotherapy to \\> 25% of bone marrow.\n* 3.Prior isotope therapy and/or brachytherapy\n* 4.Prior gene therapy.\n* 5.Active double cancer.\n* 6.Known brain or leptomeningeal involvement.\n* 7.History of hypersensitivity reaction to drug\n* 8.Other serious illness or medical condition\n* 9.Subjects whom the investigators consider inappropriate from social or medical aspects.'}, 'identificationModule': {'nctId': 'NCT00291005', 'briefTitle': 'PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'ARD6562'}, 'secondaryIdInfos': [{'id': 'XRP6976J/2101'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ARD6562, Docetaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Atsushi NAKAMURA', 'role': 'STUDY_CHAIR', 'affiliation': 'CSD, PL / TA-Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}