Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-29 @ 12:45 AM
Study NCT ID:
NCT00111020
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2005-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Protocol for the Use of Sorafenib in Patients With Advanced 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': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2567}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2005-05-16', 'studyFirstSubmitQcDate': '2005-05-16', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety parameters', 'timeFrame': 'From signing consent to 30 days after last dose of study drug'}], 'secondaryOutcomes': [{'measure': 'Limited radiological evaluations', 'timeFrame': 'At baseline, than every 8 weeks after start of sorafenib'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carcinoma, Renal Cell']}, 'referencesModule': {'references': [{'pmid': '20082451', 'type': 'DERIVED', 'citation': 'Stadler WM, Figlin RA, McDermott DF, Dutcher JP, Knox JJ, Miller WH Jr, Hainsworth JD, Henderson CA, George JR, Hajdenberg J, Kindwall-Keller TL, Ernstoff MS, Drabkin HA, Curti BD, Chu L, Ryan CW, Hotte SJ, Xia C, Cupit L, Bukowski RM; ARCCS Study Investigators. Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America. Cancer. 2010 Mar 1;116(5):1272-80. doi: 10.1002/cncr.24864.'}]}, 'descriptionModule': {'briefSummary': 'This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced (unresectable, recurrent or metastatic) RCC\n* Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy\n* Patients with an ECOG performance status of 0-2\n* Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib\n* Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice\n\nExclusion Criteria:\n\n* Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial\n* Patients who have participated in any other sorafenib trial\n* Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry\n* Life expectancy of less than two months\n* Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0\n* Patients with active coronary artery disease or ischemia\n* Patients with Child-Pugh class C hepatic impairment\n* Patients with severe renal impairment or who require dialysis\n* Patients with active uncontrolled hypertension\n* Patients with recent or active bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT00111020', 'briefTitle': 'Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '11868'}}, 'armsInterventionsModule': 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