Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00854620
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2009-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], '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': '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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sandysri@stanford.edu', 'phone': '650-725-2078', 'title': 'Sandy Srinivas, MD', 'organization': 'Stanford University, Stanford Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sorafenib', 'description': '* Cycle 1: 400 mg BID sorafenib\n* Cycle 2: 600 mg BID sorafenib\n* Cycle 3+: 800 mg BID sorafenib\n\nSorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General disorders and administration site conditions-other, Hand foot Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAEv4'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCAEv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-to-progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib', 'description': '* Cycle 1: 400 mg BID sorafenib\n* Cycle 2: 600 mg BID sorafenib\n* Cycle 3+: 800 mg BID sorafenib\n\nSorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sorafenib', 'description': '* Cycle 1: 400 mg BID sorafenib\n* Cycle 2: 600 mg BID sorafenib\n* Cycle 3+: 800 mg BID sorafenib\n\nSorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sorafenib', 'description': '* Cycle 1: 400 mg BID sorafenib\n* Cycle 2: 600 mg BID sorafenib\n* Cycle 3+: 800 mg BID sorafenib\n\nSorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects enrolled were included in the analysis'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2009-02-27', 'resultsFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2009-03-02', 'lastUpdatePostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-06', 'studyFirstPostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-to-progression (TTP)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carcinoma, Renal Cell', 'Kidney Disease', 'Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib', 'detailedDescription': 'Sorafenib to be administered as 28-day cycles.\n\nSorafenib dose escalation by cycle is:\n\n* Cycle 1: 400 mg BID\n* Cycle 2: 600 mg BID\n* Cycle 3+: 800 mg BID\n\nWithin subject dose escalation and maximum dose is dependent on observed tolerability.\n\nDose escalation only occurs after acceptable tolerability is demonstrated by subject.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).\n2. must have a component of conventional clear cell renal carcinoma.\n3. No more than one prior systemic therapy.\n4. No prior vascular endothelial growth factor receptor agents.\n5. Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided the subject has at least one measurable and/or evaluable lesion(s) that has not been irradiated.\n6. All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to Day 1 dosing. Patients must have recovered from surgery and/or radiotherapy toxicity prior to Day 1 dosing.\n7. Measureable disease by RECIST criteria\n8. Karnofsky performance status at least 70% or ECOG not more than 2\n9. Ability to give written informed consent\n10. At least 18 years old\n11. Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing potential)\n12. Sexually active fertile subjects must agree to use an accepted method of contraception during the course of the study for 3 months thereafter.\n13. ANC at least 1,500/uL\n14. Platelet count at least 100,000/uL\n15. AST/ALT not more than 2.5 times the upper limit of normal (ULN)\n16. Alkaline phosphatase not more than 2.5 x ULN\n17. Serum bilirubin not more than 1.5 x ULN\n18. Amylase/Lipase within normal range\n19. Urinalysis not more than 1+ protein\n20. Serum creatinine not more than 1.5 x ULN\n21. No active ischemia by ECG\n22. Echocardiogram or MUGA ejection fraction at least 40%\n\nExclusion Criteria:\n\n1. Ongoing hemoptysis\n2. Cerebrovascular accident within 12 months\n3. Peripheral vascular disease with claudication on less than 1 block\n4. History of clinically significant bleeding\n5. Malignancy with true papillary/sarcomatoid features without any clear cell component\n6. Chromophobe\n7. Oncocytoma\n8. Collecting duct tumors\n9. Transitional cell carcinoma\n10. Deep venous thrombosis or pulmonary embolus within one year of consent\n11. Ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed\n12. Subjects with evidence of current central nervous system (CNS) metastases\n13. MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing\n14. Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV)\n15. Angina pectoris requiring nitrate therapy\n16. Myocardial infarction within the last 6 months\n17. Uncontrolled hypertension (defined as blood pressure at least 160 mmHg systolic or at least 90 mmHg diastolic on medication)\n18. Ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.\n19. Uncontrolled psychiatric disorder\n20. Delayed healing of wounds, ulcers, and/or bone fractures\n21. Prior malignancy (EXCEPTIONS: adequately-treated basal cell or squamous cell skin cancer or any other cancer for which chemotherapy has been completed \\> 5 years ago and from which the patient has been disease-free for \\> 5 years)\n22. Pregnant\n23. Currently lactating\n24. Currently using St John's Wort (an herb)"}, 'identificationModule': {'nctId': 'NCT00854620', 'briefTitle': 'Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University', 'orgStudyIdInfo': {'id': 'IRB-04988'}, 'secondaryIdInfos': [{'id': '96919', 'type': 'OTHER', 'domain': 'Stanford Secondary IRB Approval Number'}, {'id': 'SU-02272009-1898', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': 'RENAL0009', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sorafenib', 'description': '* Cycle 1: 400 mg BID sorafenib\n* Cycle 2: 600 mg BID sorafenib\n* Cycle 3+: 800 mg BID sorafenib', 'interventionNames': ['Drug: Sorafenib']}], 'interventions': [{'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['Nexavar', 'Sorafenib tosylate'], 'description': 'Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)', 'armGroupLabels': ['Sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Dr. Sandy Srinivas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Sandy Srinivas', 'investigatorAffiliation': 'Stanford University'}}}}