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- Check5 days agoChange DetectedThe study has expanded to include 191 locations, and the website has been updated to version 2.10.0, replacing the previous version 2.9.7.SummaryDifference0.2%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma Drug Information available for: Sorafenib Tivozanib FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Tivozanib hydrochloride Participants randomized to this arm will receive the study drug, tivozanib hydrochloride. Drug : Tivozanib hydrochloride Tivozanib hydrochloride Active Comparator : Sorafenib Participants randomized to this arm will receive the comparator drug, sorafenib. Drug : Sorafenib Sorafenib Primary Outcome Measures Outcome Measure Measure Description Time Frame Progression-free Survival (PFS) The PFS, as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years) Secondary Outcome Measures Outcome Measure Measure Description Time Frame Overall Survival (OS) The OS is defined as the time from the date of randomization to date of death due to any cause. Date of randomization to date of death (up to approximately 5 years) Objective Response Rate (ORR) The ORR is defined as the percentage of participants who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1). Every 8 weeks from date of randomization until disease progression (up to approximately 5 years) Duration of Response (DOR) The DOR is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause. Assessed every 8 weeks from date of randomization until date of progression (up to approximately 5 years) Additional Relevant MeSH Terms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Kidney Diseases Urologic Diseases Male Urogenital Diseases Carcinoma Carcinoma, Renal Cell Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Sorafenib Tivozanib Plan to Share Individual Participant Data (IPD)? Undecided Study Documents Provided by AVEO Pharmaceuticals, Inc. Study Protocol [ PDF , 2.67MB, 2018-10-01 ] Statistical Analysis Plan [ PDF , 0.4MB, 2018-10-01 ] Revision: v2.9.1'SummaryDifference14%
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