Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-04 @ 8:17 PM
Study NCT ID:
NCT00606866
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2008-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
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'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'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': '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'To predict which patients are most likely to experience tumor shrinkage.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['renal, metastatic, carcinoma'], 'conditions': ['Metastatic Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic clear cell renal cell cancer;\n* At least one lesion that can be accurately measured in at least one dimension;\n* Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors;\n* Age 18 and older;\n* ECOG performance status 0-2;\n* Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;\n* Normal organ function: total bilirubin less than upper limit of normal, AST less than 2.5 X upper limit of normal, creatinine less than 2.8 mg/dl;\n* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Chemotherapy or radiotherapy within 4 weeks prior to entering the study;\n* Any other investigational agents;\n* Known brain metastases;\n* Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT00606866', 'acronym': 'MRI', 'briefTitle': 'MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '12977A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'I', 'description': 'placebo pill', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'description': 'Sorafenib, 200 mg bid', 'interventionNames': ['Drug: Sorafenib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'III', 'description': 'Sorafenib, 400 mg bid', 'interventionNames': ['Drug: Sorafenib']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo for four weeks', 'armGroupLabels': ['I']}, {'name': 'Sorafenib', 'type': 'DRUG', 'description': 'Sorafenib 200 mg twice daily', 'armGroupLabels': ['II']}, {'name': 'Sorafenib', 'type': 'DRUG', 'description': 'Sorafenib, 400 mg twice daily', 'armGroupLabels': ['III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}