Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00432302
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2007-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Mass Balance of the Test Drug and Major Metabolites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530494', 'term': 'sagopilone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2007-02-06', 'studyFirstSubmitQcDate': '2007-02-06', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477.', 'timeFrame': '14 days'}, {'measure': 'Cmax', 'timeFrame': '14 days', 'description': 'Maximum plasma concentration for \\[14C\\]-ZK 219477, ZK 219477'}, {'measure': 'tmax', 'timeFrame': '14 days', 'description': 'Time to Cmax for \\[14C\\]-ZK 219477, ZK 219477'}, {'measure': 'AUC', 'timeFrame': '14 days', 'description': 'Area under the concentration time curve for \\[14C\\]-ZK 219477, ZK 219477'}, {'measure': 'AUC(0-tlast)', 'timeFrame': '14 days', 'description': 'AUC from administration until the last time point with measurable concentration for \\[14C\\]-ZK 219477, ZK 219477'}, {'measure': 'AUC(0-24)', 'timeFrame': '14 days', 'description': 'AUC from time zero to 24 hours for \\[14C\\]-ZK 219477, ZK 219477'}, {'measure': 'MRT', 'timeFrame': '14 days', 'description': 'Mean residence time for \\[14C\\]-ZK 219477, ZK 219477'}, {'measure': 't1/2', 'timeFrame': '14 days', 'description': 'Terminal half-life for \\[14C\\]-ZK 219477, ZK 219477'}, {'measure': 'λz', 'timeFrame': '14 days', 'description': 'Apparent terminal rate constant for \\[14C\\]-ZK 219477, ZK 219477'}, {'measure': 'CL', 'timeFrame': '14 days', 'description': 'Total clearance for ZK 219477'}, {'measure': 'Vss', 'timeFrame': '14 days', 'description': 'Apparent volume of distribution at steady state for ZK 219477'}, {'measure': 'Vz', 'timeFrame': '14 days', 'description': 'Apparent volume of distribution during terminal phase for ZK 219477'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Approximately 12 weeks to 30 weeks'}, {'measure': 'Overall response', 'timeFrame': 'Approximately 10 to 32 weeks', 'description': 'Determination of complete response (CR), partial response (PR), unknown, stable disease, progressive disease (PD) by the modified Response Evaluation Criteria in Solid Tumors'}, {'measure': 'Best overall response', 'timeFrame': 'Approximately 10 to 32 weeks', 'description': "Overall response as obtained at all time points available for an individual subject combined to the 'best overall response'"}, {'measure': 'Responders', 'timeFrame': 'Approximately 10 to 32 weeks', 'description': "'Response' was considered to be established if 'Best overall response' of PR or CR was confirmed at any time after the start of study treatment. If response was established, a subject was referred to as a 'responder'"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Tumor', 'Malignancy', 'Mass Balance', 'Chemotherapy', 'Drug', 'Cancer Treatment', 'Intravenous Infusion', 'Epothilone', 'Solid Tumor'], 'conditions': ['Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male ≥ 18 years; female ≥ 50 years without childbearing potential (confirmed by either: age ≥ 60; or history of hysterectomy; or hormone analysis in serum: Estradiol ≤ 20 pg/mL and follicle stimulating hormone ≥ 40 IU/L)\n* Solid tumor\n* Adequate function of major organs\n* Failed previous cancer treatment\n* Peripheral venous access\n\nExclusion Criteria:\n\n* Concurrent severe and/or uncontrolled disease\n* Brain tumors\n* Marked constipation'}, 'identificationModule': {'nctId': 'NCT00432302', 'briefTitle': 'Investigation of Mass Balance of the Test Drug and Major Metabolites', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design', 'orgStudyIdInfo': {'id': '91490'}, 'secondaryIdInfos': [{'id': '2006-000188-26', 'type': 'EUDRACT_NUMBER'}, {'id': '310301', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sagopilone', 'description': 'Subjects received 28 mg ZK 219477, containing 14 kBq/7.8 µg \\[14C\\]-ZK 219477 in the first infusion (Treatment course 1) followed by subsequent infusions (Treatment courses 2 to n \\[till disease progression\\]) of 16 mg/m2 ZK 219477 without radioactive label. Interval between the treatments was at least 21 days.', 'interventionNames': ['Drug: Sagopilone (BAY 86-5302, ZK 219477)']}], 'interventions': [{'name': 'Sagopilone (BAY 86-5302, ZK 219477)', 'type': 'DRUG', 'description': 'First infusion only: 28 mg, containing 14 kBq/7.8 mcg \\[14C\\]-ZK 219477. Subsequent infusions: 16 mg/m2 ZK 219477 without radioactive label. IV infusion was given over a period of 30 min.', 'armGroupLabels': ['Sagopilone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}