Ignite Creation Date:
2025-12-25 @ 1:30 AM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT01353794
Status:
WITHDRAWN
Last Update Posted:
2015-01-30
First Post:
2011-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-29', 'studyFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2011-05-13', 'lastUpdatePostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy related variables are status of tumor / metastases.', 'timeFrame': 'After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)'}, {'measure': "Efficacy related variables are patient's performance status.", 'timeFrame': 'After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)'}, {'measure': 'Efficacy related variables are efficacy assessment by the physician.', 'timeFrame': 'After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)'}, {'measure': 'Efficacy related variable - Quality of Life (QOL) assessment by the patient', 'timeFrame': 'After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)'}], 'secondaryOutcomes': [{'measure': 'General tolerability assessment by physician and reports of adverse events.', 'timeFrame': 'After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SORAFENIB', 'RENAL CELL CARCINOMA', 'TYROSINE KINASE INHIBITOR', 'OBSERVATIONAL STUDY'], 'conditions': ['Carcinoma, Renal Cell']}, 'descriptionModule': {'briefSummary': 'The objective of this Non-Interventional study is to evaluate the effectiveness \\& safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age \\>70 years) and younger patients (age \\<70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of advanced RCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib\n\nExclusion Criteria:\n\n* Exclusion criteria must be read in conjunction with the local product information.'}, 'identificationModule': {'nctId': 'NCT01353794', 'acronym': 'POWER-NEXT', 'briefTitle': 'Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '15246'}, 'secondaryIdInfos': [{'id': 'NX0913IN', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Sorafenib (Nexavar, BAY43-9006)']}], 'interventions': [{'name': 'Sorafenib (Nexavar, BAY43-9006)', 'type': 'DRUG', 'description': 'The treatment with Sorafenib 200mg tablets should comply with the recommendations written in the local product information. The decision about the duration of treatment is solely at the discretion of the attending physician', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}