Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
2014年1月8日 更新者：Bayer
A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.
研究概览
详细说明
Overall Survival (OS), Patient-reported outcome (PRO)
研究类型
介入性
注册 (实际的)
903
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Donetsk、乌克兰、83092
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Kharkiv、乌克兰、61024
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Kiev、乌克兰、115
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Lviv、乌克兰、79031
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Poltava、乌克兰、36024
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Haifa、以色列、3109601
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Tel Aviv、以色列、64239
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Barnaul、俄罗斯联邦、656049
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Kazan、俄罗斯联邦、420029
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Kirov、俄罗斯联邦、610021
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Moscow、俄罗斯联邦、125284
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Moscow、俄罗斯联邦、115478
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Obninsk、俄罗斯联邦、249036
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St. Petersburg、俄罗斯联邦、198255
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Alberta
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Edmonton、Alberta、加拿大、T6G 1Z2
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Ontario
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Hamilton、Ontario、加拿大、L8V 5C2
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London、Ontario、加拿大、N6A 4L6
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Toronto、Ontario、加拿大、M5G 2M9
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Quebec
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Montreal、Quebec、加拿大、H3T 1E2
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Budapest、匈牙利、1121
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Budapest、匈牙利、1032
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Debrecen、匈牙利、4004
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Zalaegerszeg、匈牙利、8900
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Freestate
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Bloemfontein、Freestate、南非、9300
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Gauteng
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Pretoria、Gauteng、南非
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Kwazulu-Natal
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Durban、Kwazulu-Natal、南非、4001
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Western Cape
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Cape Town、Western Cape、南非、7500
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Parana
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Curitiba、Parana、巴西、81520-060
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、巴西、90619900
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Porto Alegre、Rio Grande do Sul、巴西、90020-060
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Berlin、德国、10967
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Hamburg、德国、20246
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Baden-Württemberg
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Mannheim、Baden-Württemberg、德国、68167
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Ulm、Baden-Württemberg、德国、89075
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Bayern
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München、Bayern、德国、81377
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Regensburg、Bayern、德国、93042
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Hessen
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Darmstadt、Hessen、德国、64276
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Frankfurt、Hessen、德国、60488
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Nordrhein-Westfalen
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Düsseldorf、Nordrhein-Westfalen、德国、40225
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Sachsen
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Dresden、Sachsen、德国、01307
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Milano、意大利、20133
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Modena、意大利、41124
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Pavia、意大利、27100
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Perugia、意大利、06122
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Reggio Emilia、意大利、42100
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Roma、意大利、00144
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Santiago de Chile、智利
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Bruxelles - Brussel、比利时、1000
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Bruxelles - Brussel、比利时、1090
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Bordeaux、法国、33000
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Caen Cedex 5、法国、14076
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Lille Cedex、法国、59020
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Lyon Cedex、法国、69008
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Marseille、法国、13273
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Nantes、法国、44805
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Paris Cedex 15、法国、75908
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Strasbourg、法国、67091
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Toulouse、法国、31052
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Villejuif、法国、94805
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Gdansk、波兰、80-210
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Krakow、波兰、31-115
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Lodz、波兰、93-509
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Lublin、波兰、20-090
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Poznan、波兰、61-878
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Szczecin、波兰、70-111
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Warszawa、波兰、02-781
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Warszawa、波兰、04-141
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Wroclaw、波兰、50-043
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Australian Capital Territory
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Garran、Australian Capital Territory、澳大利亚、2605
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New South Wales
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Camperdown、New South Wales、澳大利亚、2050
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Liverpool、New South Wales、澳大利亚、2170
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Westmead、New South Wales、澳大利亚、2145
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Victoria
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Heidelberg、Victoria、澳大利亚、3084
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Wodonga、Victoria、澳大利亚、0390
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Arizona
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Tucson、Arizona、美国、85712
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California
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Los Angeles、California、美国、90033
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Los Angeles、California、美国、90057
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Sacramento、California、美国、95817
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Colorado
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Aurora、Colorado、美国、80045
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Connecticut
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Hamden、Connecticut、美国、06518
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Georgia
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Atlanta、Georgia、美国、30309
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Illinois
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Chicago、Illinois、美国、60637
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Kentucky
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Louisville、Kentucky、美国、40202
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Louisiana
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Lafayette、Louisiana、美国、70506
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Maryland
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Frederick、Maryland、美国、21701
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Massachusetts
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Boston、Massachusetts、美国、02215
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Minnesota
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Minneapolis、Minnesota、美国、55455
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Missouri
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Columbia、Missouri、美国、65203-3244
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St. Louis、Missouri、美国、63110-1093
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New York
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Bronx、New York、美国、10466-2604
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Brooklyn、New York、美国、11220
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New York、New York、美国、10032
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Ohio
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Canton、Ohio、美国、44718
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Cleveland、Ohio、美国、44195
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Dayton、Ohio、美国、45429
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Oregon
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Portland、Oregon、美国、97239
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107-5096
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South Carolina
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Spartanburg、South Carolina、美国、29303
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Texas
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Dallas、Texas、美国、75246
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Laredo、Texas、美国、78041
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San Antonio、Texas、美国、78212
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Utah
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Salt Lake City、Utah、美国、84132
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Virginia
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Richmond、Virginia、美国、23229
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Washington
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Seattle、Washington、美国、98101
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Wisconsin
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Milwaukee、Wisconsin、美国、53226-3596
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Manchester、英国、M20 4BX
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Middlesex
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Northwood、Middlesex、英国、HA6 2RN
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South Glamorgan
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Cardiff、South Glamorgan、英国、CF14 2TL
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Stratchclyde
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Glasgow、Stratchclyde、英国、G11 6NT
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Surrey
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Sutton、Surrey、英国、SM2 5PT
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Tyne and Wear
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Newcastle Upon Tyne、Tyne and Wear、英国、NE4 6BE
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West Midlands
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Birmingham、West Midlands、英国、B15 2TT
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Nijmegen、荷兰、6525 GA
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Barcelona、西班牙、08035
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Madrid、西班牙、28040
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Valencia、西班牙、46009
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Bilbao
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Cruces/Barakaldo、Bilbao、西班牙、48903
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Capital Federal-Buenos Aires、阿根廷、C1426ANZ
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Mendoza、阿根廷、5500
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Santa Fe
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Rosario、Santa Fe、阿根廷、S2000DSK
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Santa Fé、Santa Fe、阿根廷、S3000FFV
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
- Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
- Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
- Patients who have adequate coagulation, liver and kidney functions
Exclusion Criteria:
- Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
- Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
- Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
- Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- Patients with a history or presence of metastatic brain or meningeal tumors
- Patients with seizure disorder requiring medication (such as anti-epileptics)
- History of organ allograft or bone marrow transplant of stem cell rescue
- Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
Patients who have three or more of the following:
- ECOG performance status greater than or equal to 2,
- Abnormally high lactate dehydrogenase,
- Abnormally high serum hemoglobin,
- Abnormally high corrected serum calcium,
- Absence of prior nephrectomy
Excluded therapies and medications, previous and concomitant:
- Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
- Significant surgery with 4 weeks of start of study
- Investigational drug therapy during or within 30 days
- Concomitant treatment with rifampin or St. John's Wort
- Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
- Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Sorafenib (Nexavar, BAY43-9006)
Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily).
Dose modification due to toxicity was permitted.
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Multi Kinase Inhibitor
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安慰剂比较：Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
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安慰剂
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
大体时间：From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
|
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause.
Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
|
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
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Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population
大体时间：From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
|
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause.
Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
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From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Final Progression-Free Survival (PFS) - Independent Radiological Review
大体时间：From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
|
PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD.
Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review.
Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.
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From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
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Best Overall Response - Independent Radiological Review
大体时间：From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
|
Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review.
Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.
|
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
|
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Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment
大体时间：From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
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Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles.
FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL.
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From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
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Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
大体时间：From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
|
Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles.
FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.
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From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Quintanilha JCF, Geyer S, Etheridge AS, Racioppi A, Hammond K, Crona DJ, Pena CE, Jacobson SB, Marmorino F, Rossini D, Cremolini C, Sanoff HK, Abou-Alfa GK, Innocenti F. KDR genetic predictor of toxicities induced by sorafenib and regorafenib. Pharmacogenomics J. 2022 Dec;22(5-6):251-257. doi: 10.1038/s41397-022-00279-3. Epub 2022 Apr 28.
- Antoun S, Birdsell L, Sawyer MB, Venner P, Escudier B, Baracos VE. Association of skeletal muscle wasting with treatment with sorafenib in patients with advanced renal cell carcinoma: results from a placebo-controlled study. J Clin Oncol. 2010 Feb 20;28(6):1054-60. doi: 10.1200/JCO.2009.24.9730. Epub 2010 Jan 19.
- Bellmunt J, Eisen T, Fishman M, Quinn D. Experience with sorafenib and adverse event management. Crit Rev Oncol Hematol. 2011 Apr;78(1):24-32. doi: 10.1016/j.critrevonc.2010.03.006. Epub 2010 Apr 18.
- Massard C, Zonierek J, Gross-Goupil M, Fizazi K, Szczylik C, Escudier B. Incidence of brain metastases in renal cell carcinoma treated with sorafenib. Ann Oncol. 2010 May;21(5):1027-31. doi: 10.1093/annonc/mdp411. Epub 2009 Oct 22.
- Negrier S, Jager E, Porta C, McDermott D, Moore M, Bellmunt J, Anderson S, Cihon F, Lewis J, Escudier B, Bukowski R. Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. Med Oncol. 2010 Sep;27(3):899-906. doi: 10.1007/s12032-009-9303-z. Epub 2009 Sep 12.
- Pena C, Lathia C, Shan M, Escudier B, Bukowski RM. Biomarkers predicting outcome in patients with advanced renal cell carcinoma: Results from sorafenib phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. Clin Cancer Res. 2010 Oct 1;16(19):4853-63. doi: 10.1158/1078-0432.CCR-09-3343. Epub 2010 Jul 22.
- Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM. Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009 Jul 10;27(20):3312-8. doi: 10.1200/JCO.2008.19.5511. Epub 2009 May 18.
- Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, Anderson S, Shah S, Bukowski R, Escudier B; TARGET Study Group. Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial. J Natl Cancer Inst. 2008 Oct 15;100(20):1454-63. doi: 10.1093/jnci/djn319. Epub 2008 Oct 7.
- Bukowski R, Cella D, Gondek K, Escudier B; Sorafenib TARGETs Clinical Trial Group. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol. 2007 Jun;30(3):220-7. doi: 10.1097/01.coc.0000258732.80710.05.
- Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. doi: 10.1056/NEJMoa060655. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.
- Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, Pazdur R. Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res. 2006 Dec 15;12(24):7271-8. doi: 10.1158/1078-0432.CCR-06-1249.
- Lamuraglia M, Escudier B, Chami L, Schwartz B, Leclere J, Roche A, Lassau N. To predict progression-free survival and overall survival in metastatic renal cancer treated with sorafenib: pilot study using dynamic contrast-enhanced Doppler ultrasound. Eur J Cancer. 2006 Oct;42(15):2472-9. doi: 10.1016/j.ejca.2006.04.023. Epub 2006 Sep 11. Erratum In: Eur J Cancer. 2007 May;43(8):1336.
- Quintanilha JCF, Racioppi A, Wang J, Etheridge AS, Denning S, Pena CE, Skol AD, Crona DJ, Lin D, Innocenti F. PIK3R5 genetic predictors of hypertension induced by VEGF-pathway inhibitors. Pharmacogenomics J. 2022 Feb;22(1):82-88. doi: 10.1038/s41397-021-00261-5. Epub 2021 Nov 13. Erratum In: Pharmacogenomics J. 2021 Dec 21;:
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2003年11月1日
初级完成 (实际的)
2006年9月1日
研究完成 (实际的)
2010年4月1日
研究注册日期
首次提交
2003年11月19日
首先提交符合 QC 标准的
2003年11月20日
首次发布 (估计)
2003年11月21日
研究记录更新
最后更新发布 (估计)
2014年2月6日
上次提交的符合 QC 标准的更新
2014年1月8日
最后验证
2014年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的