Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 5:45 PM
Study NCT ID:
NCT00468260
Status:
TERMINATED
Last Update Posted:
2009-11-19
First Post:
2007-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093788', 'term': 'epothilone B'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'whyStopped': 'pts. will be captured in core', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2009-11-18', 'studyFirstSubmitDate': '2007-05-01', 'studyFirstSubmitQcDate': '2007-05-01', 'lastUpdatePostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety'}, {'measure': 'Tolerability'}, {'measure': 'Potential activity of patupilone once every 21 days in patients that completed the core study'}], 'secondaryOutcomes': [{'measure': 'Objective response and tumor evaluation assessed by response evaluation criteria in solid tumors (RECIST)'}]}, 'conditionsModule': {'keywords': ['Cancer', 'EPO906', 'Patupilone'], 'conditions': ['Advanced Malignancies']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria Participation in study EPO906A2120E1\n\n* Age ≥ 18 years of age\n* Life expectancy ≥ 3 months\n* Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist\n* Completed all PK sampling in the core study\n\nExclusion criteria\n\n* Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis\n* Female patients who are pregnant or breast feeding\n* Patients with a severe and/or uncontrolled medical disease\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00468260', 'briefTitle': 'The Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies-extension Study', 'orgStudyIdInfo': {'id': 'CEPO906A2120E1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patupilone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}