Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-27 @ 5:28 AM
Study NCT ID:
NCT01042795
Status:
TERMINATED
Last Update Posted:
2017-06-28
First Post:
2010-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cheryl.lee@osumc.edu', 'phone': '614-685-6666', 'title': 'Cheryl T. Lee', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '21.5 months - after that point no one was still in the trial', 'eventGroups': [{'id': 'EG000', 'title': 'Continuous Daily Dosing of Sunitinib', 'description': 'Sunitinib: Sunitinib 37.5 mg daily X 16 weeks', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Daily Dosing of Sunitinib', 'description': 'Sunitinib: Sunitinib 37.5 mg daily X 16 weeks'}], 'classes': [{'title': 'Patient 1 Time to Recurrence', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Patient 2 Last Follow up. No Recurrence', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'Patient 3 Time to Recurrence', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}]}]}, {'title': 'Patient 4 Last Follow up. No Recurrence', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}]}]}, {'title': 'Patient 5 Last Follow up. No Recurrence', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}]}]}, {'title': 'Patient 6 Time to Recurrence', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}]}]}, {'title': 'Patient 7 Last Follow up. No Recurrence', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2- year', 'description': '2-year disease free survival', 'unitOfMeasure': 'months', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continuous Daily Dosing of Sunitinib', 'description': 'Sunitinib: Sunitinib 37.5 mg daily X 16 weeks'}], 'periods': [{'title': 'Dosing Period - 16 Weeks of Daily Doses', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}, {'title': 'Follow up - 22 Months After Drug Start', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Continuous Daily Dosing of Sunitinib', 'description': 'Sunitinib: Sunitinib 37.5 mg daily X 16 weeks'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-85 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Study closed due to poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2010-01-05', 'resultsFirstSubmitDate': '2017-04-11', 'studyFirstSubmitQcDate': '2010-01-05', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-26', 'studyFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Free Survival', 'timeFrame': '2- year', 'description': '2-year disease free survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sunitinib', 'bladder neoplasm', 'adjuvant treatment', 'disease free survival', 'cystectomy'], 'conditions': ['Urothelial Carcinoma', 'Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether sutent (sunitinib)is effective in preventing tumor recurrence in patients with high risk bladder cancer who have previously had chemotherapy and cystectomy (bladder removal).\n\nA 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal. The patients are followed up to 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic diagnosis of bladder carcinoma (\\>50% urothelial carcinoma)\n* Prior treatment with at least one cycle of platin-based neoadjuvant chemotherapy\n* Prior treatment with radical cystectomy revealing pT3NxM0 or pTanyN+M0\n* ECOG performance status of 0-1 (Appendix 2).\n* No evidence of metastases within 4 weeks of registration\n* Adequate organ and marrow function obtained within 14 days of registration\n\nExclusion Criteria:\n\n* Severe or uncontrolled acute or chronic medical or psychiatric condition\n* Prior antiangiogenic therapy\n* Prior pelvic radiation for bladder cancer'}, 'identificationModule': {'nctId': 'NCT01042795', 'briefTitle': 'Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy', 'orgStudyIdInfo': {'id': 'HUM00030127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous Daily Dosing of Sunitinib', 'interventionNames': ['Drug: Sunitinib']}], 'interventions': [{'name': 'Sunitinib', 'type': 'DRUG', 'otherNames': ['Sutent'], 'description': 'Sunitinib 37.5 mg daily X 16 weeks', 'armGroupLabels': ['Continuous Daily Dosing of Sunitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Urology', 'investigatorFullName': 'Cheryl Lee', 'investigatorAffiliation': 'University of Michigan'}}}}