Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-25 @ 9:39 PM
Study NCT ID:
NCT00350051
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2006-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
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': 'C530494', 'term': 'sagopilone'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2009-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2006-07-07', 'studyFirstSubmitQcDate': '2006-07-07', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles', 'timeFrame': 'at least 28 days post day 21 of last cycle of treatment'}], 'secondaryOutcomes': [{'measure': 'Safety & Tolerability of ZK-Epo plus prednisone', 'timeFrame': 'until progression, unknown duration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Metastatic androgen-independent prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '22850553', 'type': 'RESULT', 'citation': 'Beer TM, Smith DC, Hussain A, Alonso M, Wang J, Giurescu M, Roth K, Wang Y. Phase II study of first-line sagopilone plus prednisone in patients with castration-resistant prostate cancer: a phase II study of the Department of Defense Prostate Cancer Clinical Trials Consortium. Br J Cancer. 2012 Aug 21;107(5):808-13. doi: 10.1038/bjc.2012.339. Epub 2012 Jul 31.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer Healthcare products.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.', 'detailedDescription': 'This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have evidence of confirmed metastatic prostate cancer\n* Serum testosterone must be less than 50 ng/mL\n* Disease must be progressing despite anti-androgen therapy\n* PSA level must be elevated\n* Additional criteria determined at screening visit\n\nExclusion Criteria:\n\n* Any previous cytotoxic chemotherapy for prostate cancer\n* Use of any investigational drug in the last 4 weeks\n* Symptomatic brain tumors requiring radiation to the brain\n* Active infection\n* Additional criteria determined at screening visit'}, 'identificationModule': {'nctId': 'NCT00350051', 'briefTitle': 'ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer', 'nctIdAliases': ['NCT00430222'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer', 'orgStudyIdInfo': {'id': '91500'}, 'secondaryIdInfos': [{'id': '307976', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Sagopilone (ZK 219477) + prednisone']}], 'interventions': [{'name': 'Sagopilone (ZK 219477) + prednisone', 'type': 'DRUG', 'description': 'Chemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '34237', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '68198-7680', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10469', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '16601', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '98108-1597', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'C1280AEB', 'city': 'Buenos Aires', 'state': 'Ciudad Auton. de Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1406', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1405DCS', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1416CRJ', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'X5016KEH', 'city': 'Córdoba', 'country': 'Argentina', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}