Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-07 @ 7:01 AM
Study NCT ID:
NCT00830895
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2009-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-06', 'studyFirstSubmitDate': '2009-01-27', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2 months, 4 months, 6 months', 'description': 'It is the time from treatment initiation until disease progression.'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '2 months, 4 months, 6 months', 'description': 'It is the percentage of patients whose cancer shrinks or disappears after treatment.'}, {'measure': 'Disease-control rate', 'timeFrame': '2 months, 4 months, 6 months', 'description': 'It is the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention.'}, {'measure': 'Overall survival', 'timeFrame': '2 months, 4 months, 6 months', 'description': 'The length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive.'}, {'measure': 'Metabolic response rate by FDG-PET', 'timeFrame': '2 months, 4 months, 6 months', 'description': 'It is assesed target lesions and non- target lesions by FDG-PET.'}, {'measure': 'Safety', 'timeFrame': 'monthly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal cell carcinoma', 'Non-clear cell', 'RAD001', 'Metastatic, non-clear cell, renal cell carcinoma'], 'conditions': ['Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '23180114', 'type': 'DERIVED', 'citation': 'Koh Y, Lim HY, Ahn JH, Lee JL, Rha SY, Kim YJ, Kim TM, Lee SH. Phase II trial of everolimus for the treatment of nonclear-cell renal cell carcinoma. Ann Oncol. 2013 Apr;24(4):1026-31. doi: 10.1093/annonc/mds582. Epub 2012 Nov 23.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly)\n2. Subjects with metastatic legion\n3. Subjects aged 18 years or older\n4. Subjects whose ECOG performance status is 0 or 1\n5. Subjects who have laboratory value below; Hematology\n\n * Neutrophil \\>= 1.5 x 109/L\n * Platelet \\>= 75 x 109/L\n * Hemoglobin \\>= 9 g/dL Liver function tests\n * Total bilirubin ≤ 1.5 xULN\n * AST, ALT ≤ 2.5 xULN\n * Alkaline phosphatase ≤ 2.5 xULN Renal function tests\n * Creatinine clearance \\>= 30 mL/min\n6. Subjects who understand and provide a written informed consent\n\nExclusion Criteria:\n\n1. Subjects who have been administered an mTOR inhibitor\n2. Pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative\n3. Subjects who participated in a clinical study using the study medication within 30 days before randomization\n4. Subjects with clinically uncontrolled central nervous system (CNS) metastasis\n5. Subjects with life expectancy of less than 3 months\n6. Subjects with interstitial pulmonary disease\n7. Subjects whose QTc interval is prolonged (QTc \\> 450 msec for male or \\> 470 msec for female)\n8. Other serious diseases or medical conditions Heart disease unstable despite treatment History of myocardial infarction within six months before the study History of serious neurological or psychological disorder including dementia or seizure Active peptic ulcer which cannot be controlled by a drug'}, 'identificationModule': {'nctId': 'NCT00830895', 'briefTitle': 'RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'SNUH-RENAL-0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RAD001', 'description': 'RAD001 10mg/day', 'interventionNames': ['Drug: RAD001']}], 'interventions': [{'name': 'RAD001', 'type': 'DRUG', 'description': 'RAD001 10mg/day', 'armGroupLabels': ['RAD001']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Se-Hoon Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}