Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT00514267
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2007-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'C523798', 'term': 'sepantronium'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D011241', 'term': 'Prednisone'}], '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'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'dispFirstSubmitDate': '2015-07-23', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-23', 'studyFirstSubmitDate': '2007-08-07', 'dispFirstSubmitQcDate': '2015-07-23', 'studyFirstSubmitQcDate': '2007-08-08', 'dispFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)', 'timeFrame': '2 cycles'}, {'measure': 'Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)', 'timeFrame': '1 cycle'}], 'secondaryOutcomes': [{'measure': 'Assessment of safety and efficacy', 'timeFrame': '10 cycles'}, {'measure': 'Assessment of pharmacokinetics', 'timeFrame': 'Part 1 only'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'HRPC', 'Hormone Refractory Prostate Cancer', 'YM155', 'Treatment Outcome', 'Solid Tumors'], 'conditions': ['Prostate Cancer', 'Tumors']}, 'descriptionModule': {'briefSummary': 'To determine the feasibility and safety of administering YM155 in combination with docetaxel', 'detailedDescription': 'This clinical trial is designed to include two parts:\n\nPart 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) \\[ ENROLLMENT COMPLETED \\]\n\nPart 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).\n\nThis registration has been updated to reflect the design requirements of PART 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart 1:\n\n* Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.\n\nPart 2:\n\n* Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).\n\nExclusion Criteria:\n\n* Radiation therapy within 4 weeks of the start of study drug'}, 'identificationModule': {'nctId': 'NCT00514267', 'briefTitle': 'An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors', 'orgStudyIdInfo': {'id': '155-CL-025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. HRPC', 'interventionNames': ['Drug: YM 155', 'Drug: Docetaxel', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': '2. Solid Tumors', 'interventionNames': ['Drug: YM 155', 'Drug: Docetaxel']}], 'interventions': [{'name': 'YM 155', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['1. HRPC', '2. Solid Tumors']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['1. HRPC', '2. Solid Tumors']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['1. HRPC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}