Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01219751
Status:
UNKNOWN
Last Update Posted:
2011-06-17
First Post:
2010-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney 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': 'D007674', 'term': 'Kidney 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-16', 'studyFirstSubmitDate': '2010-10-12', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'up to 12 months', 'description': 'Tumor response is to be measured every 6 weeks. RECIST v.1.1 will be used to definte target lesion and non-target lesion and classify the response category.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'up to 24 months', 'description': 'Form the date of enrollment to the date of the first documented disease progression or death from any cause, which came first.'}, {'measure': 'overall survival', 'timeFrame': 'up to 36 months'}, {'measure': 'Safety', 'timeFrame': 'up to 24 months', 'description': 'Safety will be assessed using CTCAE v.3.0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '22228449', 'type': 'DERIVED', 'citation': 'Lee JL, Ahn JH, Lim HY, Park SH, Lee SH, Kim TM, Lee DH, Cho YM, Song C, Hong JH, Kim CS, Ahn H. Multicenter phase II study of sunitinib in patients with non-clear cell renal cell carcinoma. Ann Oncol. 2012 Aug;23(8):2108-2114. doi: 10.1093/annonc/mdr586. Epub 2012 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma', 'detailedDescription': 'There have been no standard treatment in non-clear cell renal cell carcinoma. Retrospective studies showed sunitinib or sorafenib might be active in non-clear cell renal cell carcinoma, especially papillary type and chromophobe type.\n\nThis study is to evaluate efficacy and safety of sunitinib in this group of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmation of renal cell carcinoma without a clear cell histologic component, e.g., papillary type, chromophobe type, or collecting duct type\n2. Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.\n3. Measurable disease according to RECIST criteria\n4. ECOG performance status 1 or better\n5. Age 18 years or older\n6. Adequate cardiac function\n7. Adequate bone marrow, hepatic, and renal function\n8. Life expectancy of ≥ 3 months\n9. Singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment\n\nExclusion Criteria:\n\n1. Clear cell type renal cell carcinoma or sarcomatoid carcinoma without any clue to the primary type\n2. Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri\n3. Hypertension that cannot be controlled by medications (blood pressure \\> 150/90 mmHg despite optimal medical therapy)\n4. Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day).\n5. Pregnancy or breast feeding.\n6. Other severe acute or chronic medical or psychiatric condition\n7. Prior treatment on sunitinib, sorafenib, or bevacizumab.'}, 'identificationModule': {'nctId': 'NCT01219751', 'briefTitle': 'Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Phase II Trial Of Sunitinib In Advanced Non-Clear Cell Type Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'UOSG_AMC_0801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sunitinib', 'description': 'Sunitinib 50 mg D1-D28 every 6 weeks', 'interventionNames': ['Drug: Sunitinib']}], 'interventions': [{'name': 'Sunitinib', 'type': 'DRUG', 'otherNames': ['Sutene'], 'description': 'Sunitinib 50 mg D1-D28 every 6 weeks', 'armGroupLabels': ['Sunitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Lyun Lee, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jae Lyun Lee/Professor', 'oldOrganization': 'Asan Medical Center'}}}}