4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / 培唑帕尼辅助治疗对术后肾细胞癌的有效性和安全性研究

培唑帕尼辅助治疗对术后肾细胞癌的有效性和安全性研究

登记号 CTR20131447 试验状态 进行中
申请人联系人 卢启应 首次公示信息日期 2014-12-18
申请人名称 Glaxo Operations UK Limited/ 葛兰素史克(中国)投资有限公司/ Glaxo Group Limited
一、题目和背景信息
登记号 CTR20131447
相关登记号
药物名称 培唑帕尼
药物类型 化学药物
临床申请受理号 企业选择不公示
适应症 肾细胞癌辅助治疗
试验专业题目 随机、双盲、安慰剂对照、III期研究评价培唑帕尼辅助治疗肾切除术后的局限期肾癌患者的有效性和安全性
试验通俗题目 培唑帕尼辅助治疗对术后肾细胞癌的有效性和安全性研究
试验方案编号 VEG113387 方案最新版本号
版本日期: 方案是否为联合用药 企业选择不公示
二、申请人信息
申请人名称
1
2
3
联系人姓名 卢启应 联系人座机 021-61590309 联系人手机号
联系人Email apollo.l.lu@gsk.com 联系人邮政地址 上海浦东张江哈雷路917弄1号楼 联系人邮编 201203
三、临床试验信息
1、试验目的
评价培唑帕尼作为辅助治疗对肾切除术后局限性或局部进展性肾细胞癌患者的有效性和安全性。
2、试验设计
试验分类 安全性和有效性 试验分期 III期 设计类型 平行分组
随机化 随机化 盲法 双盲 试验范围 国际多中心试验
3、受试者信息
年龄 18岁(最小年龄)至 无岁(最大年龄)
性别 男+女
健康受试者
入选标准
1 诊断为肾细胞癌,组织学为透明细胞或以透明细胞为主型。
2 符合基线期无病状态的标准。
3 器官系统功能良好
4 非转移性疾病(M0)受试者,符合综合2010年版AJCC 病理TNM分期标准和Fuhrman核分级之一:1)pT2,G3或G4,N0;或者 2)pT3,Gany,N0;或者 3)pT4,Gany,N0:或者 4)pTany,Gany,N1
5 过去未接受过针对RCC的辅助治疗或新辅助治疗。
排除标准
1 局部复发RCC、双侧RCC或其它恶性肿瘤病史
2 慢性活动性肝炎的病史,包括乙肝病毒(HBV)或丙肝病毒(HCV)携带者
3 人类免疫缺陷病毒(HIV)感染病史
4 具有临床意义的、可能会增加胃肠道出血风险的胃肠道异常
4、试验分组
试验药
序号 名称 用法
1 中文通用名:培唑帕尼
用法用量:片剂;规格200mg;口服,每天一次,起始剂量每次 600mg, 用药时程,连续用药,共计8到12周;然后根据受试者的安全性和耐受性,由研究者根据方案规定决定是否增加到800mg剂量水平或者保持600mg剂量水平。治疗总时程为12个月。
对照药
序号 名称 用法
1 中文通用名:安慰剂
用法用量:片剂;规格200mg;口服,每天一次,起始剂量每次 600mg, 用药时程,连续用药,共计8到12周;然后根据受试者的安全性和耐受性,由研究者根据方案规定决定是否增加到800mg剂量水平或者保持600mg剂量水平。治疗总时程为12个月。
5、终点指标
主要终点指标及评价时间
序号 指标 评价时间 终点指标选择
1 无病生存期(DFS) 当获得578个DFS事件时进行评价。 有效性指标
次要终点指标及评价时间
序号 指标 评价时间 终点指标选择
1 总生存期(OS) 当获得578个DFS事件时进行评价。 有效性指标
2 生活质量 当获得578个DFS事件时进行评价。 有效性指标+安全性指标
3 安全性和耐受性 当获得578个DFS事件时进行评价。 安全性指标
4 年DFS率(如1年、2年等) 当获得578个DFS事件时进行评价。 有效性指标
6、数据安全监查委员会(DMC)
7、为受试者购买试验伤害保险
四、研究者信息
1、主要研究者信息
1 姓名 Robert Motzer 学位 职称 教授
电话 001 (646) 422-4312 Email motzerr@mskcc.org 邮政地址 1275 York Avenue, New York, United States
邮编 10065 单位名称 Memorial Sloan-Kettering Cancer Ctr-New York-United States
2、各参加机构信息
序号 机构名称 主要研究者 国家 省(州) 城市
1 Memorial Sloan-Kettering Cancer Ctr-New York-United States-C Robert Motzer United States New York New York
2 北京大学第一医院 金杰 中国 北京 北京
3 中国医学科学院肿瘤医院 王金万 中国 北京 北京
4 上海交通大学医学院附属仁济医院 黄翼然 中国 上海 上海
5 天津肿瘤医院 姚欣 中国 天津 天津
6 北京大学第三医院 马潞林 中国 北京 北京
7 浙江大学医学院附属第一医院 谢立平 中国 浙江 杭州
8 复旦大学附属华山医院 丁强 中国 上海 上海
9 浙江大学医学院附属第二医院 杜传军 中国 浙江 杭州
10 上海瑞金医院 沈周俊 中国 上海 上海
11 华中科技大学同济医学院附属同济医院 叶章群 中国 湖北 武汉
12 复旦大学附属肿瘤医院 叶定伟 中国 上海 上海
13 COIBA Centro de oncología e investig-Berazategui Mirta Varela Argentina Buenos Aires Berazategui
14 Instituto Alexander Fleming-Capital Federal Matias Chacon Argentina Buenos Aires Capital Federal
15 Hospital Alemán-Ciudad de Buenos Aires Carlos Bas Argentina Buenos Aires Ciudad de Buenos Aires
16 Instituto de Investigaciones Clinicas Cipolletti-Cipolletti Juan Lacava Argentina Río Negro Cipolletti
17 CER Instituto Medico-Quilmes Mirta Varela Argentina Quilmes Quilmes
18 Instituto Oncologico de Cordoba-Cordoba Martin Richardet Argentina Córdova Córdoba
19 Instituto Médico Especializado-Ciudad de Buenos Aires Gustavo Jankilevich Argentina Buenos Aires Ciudad de Buenos Aires
20 Centro Oncologico de Rosario-Rosario Luis Fein Argentina Santa Fe Rosario
21 CEMIC-Ciudad Autonoma de Bueno Gonzalo Recondo Argentina Buenos Aires Ciudad Autonoma de Bueno
22 Hospital Britanico de Buenos Aires-Ciudad Autónoma de Bueno Ernesto Korbenfeld Argentina Buenos Aires Ciudad Autonoma de Buenos Aires
23 Fundacion RUSCULLEDA-Córdoba Norma Pilnik Argentina Córdova Córdoba
24 ISIS Clinica Especializada-Santa Fe Cesar Blajman Argentina Santa Fe Santa Fe
25 Sanatorio de la Providencia-Ciudad Autonoma de Bueno Guillermo Lerzo Argentina Buenos Aires Ciudad Autónoma de Buenos Aires
26 Investigaciones Clinicas Ciudad Autonoma de Buenos-Buenos Aires Guillermo Lerzo Argentina Buenos Aires Ciudad Autónoma de Buenos Aires
27 Centro Medico San Roque-San Miguel de Tucuman Juan Zarba Argentina San Miguel de Tucumán San Miguel de Tucumán
28 Universitaetsklinik Innsbruck-Innsbruck Hannes Steiner Austria Innsbruck Innsbruck
29 LKH Salzburg-Salzburg Günter Janetschek Austria Salzburg Salzburg
30 LKH Salzburg-Salzburg Richard Greil Austria Salzburg Salzburg
31 AKH Wien-Vienna Gero Kramer Austria Vienna Vienna
32 LKH Graz-Graz Georg Hutterer Austria Graz Graz
33 KH Hietzing mit Neurolog. Zentrum Rosenhügel-Vienna Klaus Geissler Austria Vienna Vienna
34 Centre Hospitalier Universitaire de Liège-Liege Christine Gennigens Belgium Liège Liège
35 Clinique St Elisabeth-Namur Jean-Charles Goeminne Belgium Namur Namur
36 AZ St Augustinus-Wilrijk Jean Vandebroek Belgium Wilrijk Wilrijk
37 UZ Brussel-Brussel Denis Schallier Belgium Jette Jette
38 Heilig Hart Ziekenhuis 3-Roeselare Filip Van Aelst Belgium Roeselare Roeselare
39 JESSA Ziekenhuis Campus Virga Jesse-Hasselt Eric Joosens Belgium Hasselt Hasselt
40 Hospital Erasto Gaertner-Curitiba Murilo Luz Brazil Paraná Curitiba
41 Hospital Israelita Albert Einstein-Sao Paulo Oren Smaletz Brazil Sao Paulo Sao Paulo
42 Hospital das Clínicas da Universidade Federal-Belo Horizonte Lucas Nogueira Brazil Minas Gerais Belo Horizonte
43 Instituto Nacional do Cancer - INCA-Rio de Janeiro Fabio Peixoto Brazil Rio De Janeiro Rio de Janeiro
44 Hospital Sirio Libanes-Sao Paulo Ciro Eduardo de Souza Brazil Sao Paulo Sao Paulo
45 Universidade Estadual de Campinas (UNICAMP)-Campinas Ubirajara Ferreira Brazil Sao Paulo Campinas
46 Hospital Universitário Pedro Ernesto-UERJ-Rio de Janeiro Ronaldo Damiao Brazil Rio De Janeiro Rio De Janeiro
47 Instituto do Cancer do Estado de Sao Paulo-Sao Paulo Carlos Dzik Brazil Sao Paulo Sao Paulo
48 Fundacao PIO XII - Hospital de Cancer de Barretos-Barretos Sergio Serrano Brazil Sao Paulo Barretos
49 Clinica de Oncologia Medica-Sao Paulo Ricardo Caponero Brazil Sao Paulo Sao Paulo
50 Hospital de Caridade de Ijui-Ijui Fabio Franke Brazil Rio Grande Do Sul Ijui
51 Hospital santa marcelina-Sao Paulo Roberto Rocha Brazil Sao Paulo Sao Paulo
52 PUC-RS/Hospital Sao Lucas-Porto Alegre Carlos Henrique Brazil Rio Grande Do Sul Porto Alegre
53 Cross Cancer Institute-Edmonton Scott North Canada Alberta Edmonton
54 Tom Baker Cancer Centre-Calgary Daniel Heng Canada Alberta Calgary
55 London Health Sciences Centre- Lawson Health-London Eric Winquist Canada Ontario London
56 Ottawa Regional Cancer Centre-Ottawa Martin Reaume Canada Ontario Ottawa
57 Lakeridge Health-Oshawa Pawel Zalewski Canada Ontario Oshawa
58 Princess Margaret Hospital-Toronto Jennifer Knox Canada Ontario Toronto
59 CHUQ-Hotel Dieu de Quebec-Quebec Louis Lacombe Canada Québec Québec
60 The Moncton Hospital-Moncton Hazem Assi Canada New Brunswick Moncton
61 Queen Elizabeth II Health Sciences Centre 2-Halifax Lori Wood Canada Nova Scotia Halifax
62 Juravinski Cancer Centre-Hamilton Anil Kapoor Canada Ontario Hamilton
63 CHUM Hopital Notre Dame-Quebec Denis Soulieres Canada Québec Montreal
64 Vancouver Prostate Centre-Vancouver Christian Kollmannsberger Canada British Columbia Vancouver
65 Sunnybrook Health Sciences Centre-Toronto Georg Bjarnason Canada Ontario Toronto
66 Fundación Arturo López Pérez-Santiago-Chile-C Pamela Salman Chile Región Metro De Santiago Santiago
67 Instituto Oncologico-Vina del Mar-Chile-C Pablo Gonzalez Mella Chile Valparaíso Vina del Mar
68 Masarykova nemocnice-Usti nad Labem-Czech Republic-C Milan Lysy Czech Republic Usti nad Labem Usti nad Labem
69 VFN Praha 2-Praha 2-Czech Republic-C Milada Zemanova Czech Republic Praha 2 Praha 2
70 Nemocnice Na Bulovce-Praha 8-Czech Republic-C Vladimira Stahalova Czech Republic Praha 8 Praha 8
71 FNsP u sv. Anny-Brno-Czech Republic-C Jana Katolicka Czech Republic Brno Brno
72 FN Plzen 2-Plzen-Czech Republic-C Jindrich Finek Czech Republic Plzen Plzen
73 FN Hradec Kralove 5-Hradec Kralove-Czech Republic-C Eugen Kubala Czech Republic Hradec Kralove Hradec Kralove
74 FN Olomouc-Olomouc-Czech Republic-C Bohuslav Melichar Czech Republic Olomouc Olomouc
75 FNsP Ostrava- Poruba-Ostrava - Poruba-Czech Republic-C David Feltl Czech Republic Ostrava - Poruba Ostrava - Poruba
76 Masarykuv onkologicky ustav-Brno-Czech Republic-C Jiri Tomasek Czech Republic Brno Brno
77 Nemocnice Novy Jicin-Novy Jicin-Czech Republic-C Hana Perkova Czech Republic Novy Jicin Novy Jicin
78 Herlev Hospital-Herlev-Denmark-C Poul Geertsen Denmark Herlev Herlev
79 Aarhus Universitetshospital, Aarhus Sygehus-Aarhus-Denmark-C Frede Donskov Denmark Aarhus Aarhus
80 Odense Universitetshospital-Odense C-Denmark-C Niels Jensen Denmark Odense C Odense C
81 Centre Francois Baclesse-Caen cedex 5-France-C Emmanuel Sevin France Caen Cedex 05 Caen Cedex 05
82 Institut Mutualiste Montsouris-Paris-France-C Mostefa Bennamoun France Paris Paris
83 Centre Eugène Marquis-Rennes-France-C Brigitte Laguerre France Rennes Rennes
84 CHU de Poitiers - Hopital de la Milétrie-Poitiers cedex-France-C Jean-Marc Tourani France Poitiers Cedex Poitiers Cedex
85 HUS - Nouvel Hopital Civil-Strasbourg cedex-France-C Brigitte Duclos France Strasbourg Cedex Strasbourg Cedex
86 Institut de Cancérologie Paul Papin-Angers cedex 9-France-C Sophie Abadie-Lacourtoisie France Angers cedex 9 Angers cedex 9
87 Institut Cancérologie de l’Ouest - René Gauducheau-Saint-Herblain cedex-France-C Frédéric Rolland France Saint Herblain Saint Herblain
88 Hopital Européen Georges Pompidou-Paris cedex 15-France-C Stéphane Oudard France Paris Cedex 15 Paris Cedex 15
89 Polyclinique Courlancy-Reims-France-C Philippe Colin France Reims Reims
90 CHRU de Tours - Hopital Bretonneau-Tours cedex 9-France-C Claude Linassier France Tours Cedex 9 Tours Cedex 9
91 Clinique Sainte Marguerite-Hyeres-France-C Jean-Francois France Hyeres Hyeres
92 CHU de Montpellier - Hopital Saint-Eloi-Montpellier cedex 5-France-C Delphine Topart France Montpellier Cedex 5 Montpellier Cedex 5
93 CHU de Bordeaux - Hopital Saint André-Bordeaux-France-C Marine Gross-Goupil France Bordeaux Bordeaux
94 Centre Léon Bérard-Lyon cedex 08-France-C Sylvie Negrier France Lyon Cedex 08 Lyon Cedex 08
95 CHU de Marseille - Hopital de la Timone-Marseille cedex 5-France-C Jean Laurent Deville France Marseille cedex 5 Marseille cedex 5
96 CHU de Besancon - Hopital Jean Minjoz-Besancon cedex-France-C Antoine Thiery Vuillemin France Besancon cedex Besancon cedex
97 Centre Jean Bernard - Clinique Victor Hugo-Le Mans-France-C Eric Voog France Le Mans Le Mans
98 Clinique Pasteur-Toulouse-France-C Alain Gratet France Toulouse Toulouse
99 Clinique Sainte Anne-Strasbourg cedex-France-C Louis-Marie Dourthe France Strasbourg cedex Strasbourg cedex
100 Gem. Praxis Drs. Woerner und Rudolph-Kirchheim-Germany-C Robert Rudolph Germany Baden-Wuerttemberg Kirchheim
101 Universitaetsklinikum Marburg-Urologie-Marburg-Germany-C Axel Hegele Germany Hessen Marburg
102 Praxis Dr. med. Jochen Wilke-Fuerth-Germany-C Harald Wagner Germany Bayern Fuerth
103 Helios Klinikum Erfurt-Urologie-Erfurt-Germany-C Thomas Steiner Germany Freistaat Thüringen Erfurt
104 Universitaetsklinikum Bonn-Urologie-Bonn-Germany-C Stefan Hauser Germany Nordrhein-Westfalen Bonn
105 Klinikum Offenbach GmbH-Urologische Klinik-Offenbach-Germany-C Michael Lein Germany Hessen Offenbach
106 Universitaetsklinikum Muenster-Urologie-Muenster-Germany-C Edwin Herrmann Germany Nordrhein-Westfalen Muenster
107 Uniklinik Schleswig-Holstein-Campus Luebeck-Urolog-Luebeck-Germany-C Christian Doehn Germany Schleswig-Holstein Luebeck
108 Universitaetsklinikum des Saarlandes-Urologie-Homburg/Saar-Germany-C Stefan Siemer Germany Saarland Homburg
109 Universitaetsklinikum Ulm-Urologie-Ulm-Germany-C Mark Schrader Germany Baden-Wuerttemberg Ulm
110 Praxis Dr. med. Ralf Eckert-Eisleben-Germany-C Ralf Eckert Germany Sachsen-Anhalt Eisleben
111 Charite-Campus Mitte-Urologie-Berlin-Germany-C Ahmed Magheli Germany Berlin Berlin
112 Universitaetsklinikum Aachen-Urologie-Aachen-Germany-C Axel Heidenreich Germany Nordrhein-Westfalen Aachen
113 Praxis Dr. med. Goetz Geiges-Berlin-Germany-C Goetz Geiges Germany Berlin Berlin
114 Katharinenhospital Stuttgart-Stuttgart-Germany-C Jan Schleicher Germany Baden-Wuerttemberg Stuttgart
115 Universitaetsklinikum Jena-Urologie-Jena-Germany-C Marc-Oliver Grimm Germany Thueringen Jena
116 Krankenhaus Am Urban-Berlin-Germany-C Wolfgang Pokrzywnitzki Germany Berlin Berlin
117 Waldkrankenhaus St. Marien-Erlangen-Germany-C Peter Goebell Germany Bayern Erlangen
118 Praxis Dr. med. Toralf Kellner-Plauen-Germany-C Toralf Kellner Germany Sachsen Plauen
119 Klinikum rechts der Isar-Urologie-Muenchen-Germany-C Juergen Gschwend Germany Bayern Muenchen
120 Klinikum der J. W. Goethe-Universitaet-Med. K. II-Frankfurt-Germany-C Lothar Bergmann Germany Hessen Frankfurt
121 Kreiskrankenhaus Sigmaringen-Urologie-Sigmaringen-Germany-C Zoltan Varga Germany Baden-Wuerttemberg Sigmaringen
122 Praxis Dr. med. Hans Werner Tessen-Goslar-Germany-C Hans Werner Tessen Germany Niedersachsen Goslar
123 Universitaetsklinikum der GHS Essen-Tumorforschung-Essen-Germany-C Johannes Meiler Germany Nordrhein-Westfalen Essen
124 Martin-Luther-Universitaet Halle-Urologie-Halle-Germany-C Paolo Fornara Germany Sachsen-Anhalt Halle
125 Johannes-Gutenberg-Universitaet Mainz-Urologie-Mainz-Germany-C Christian Hampel Germany Rheinland-Pfalz Mainz
126 Studienzentrum Onkologie Ravensburg im Brustzentru-Ravensburg-Germany-C Thomas Decker Germany Baden-Wuerttemberg Ravensburg
127 Staedtische Kliniken Neuss Lukaskrankenhaus-Urol.-Neuss-Germany-C Thomas Otto Germany Nordrhein-Westfalen Neuss
128 Caritas-Krankenhaus St. Josef-Urologie-Regensburg-Germany-C Stefan Denzinger Germany Bayern Regensburg
129 Duisburger Fachaerztegemeinschaft Urologie-Duisburg-Germany-C Eva Hellmis Germany Nordrhein-Westfalen Duisburg
130 Klinikum Nordoberpfalz-Weiden-Urologie-Weiden-Germany-C Theodor Klotz Germany Bayern Weiden
131 Zeisigwaldkliniken Bethanien-Urologie-Chemnitz-Germany-C Dirk Fahlenkamp Germany Sachsen Chemnitz
132 Universitaetsklinikum Eppendorf-Urologie-Hamburg-Germany-C Roman Heuer Germany Hamburg Hamburg
133 Medizinische Hochschule Hannover-Urologie-Hannover-Germany-C Markus Kuczyk Germany Niedersachsen Hannover
134 Diakonissenkrankenhaus Dessau gGmbH-Urologie-Dessau-Germany-C Udo Rebmann Germany Sachsen-Anhalt Dessau
135 Klinikum Bremen-Mitte gGmbH-Urologische Klinik-Bremen-Germany-C Sebastian Melchior Germany Bremen Bremen
136 Universitaetsklinikum Tuebingen-Urologie-Tuebingen-Germany-C Arnulf Stenzl Germany Baden-Wuerttemberg Tuebingen
137 Klinikum Braunschweig-Urologische Klinik-Braunschweig-Germany-C Peter Hammerer Germany Niedersachsen Braunschweig
138 Kliniken Maria Hilf-Klinik fuer Urologie-Moenchengladbach-Germany-C Herbert Sperling Germany Nordrhein-Westfalen Moenchengladbach
139 Marien-Krankenhaus-Bergisch Gladbach-Germany-C Stefan Machtens Germany Nordrhein-Westfalen Bergisch Gladbach
140 Gem. Praxis Drs. Nusch und Kalhori-Velbert-Germany-C Arnd Nusch Germany Nordrhein-Westfalen Velbert
141 Klinikum Grosshadern-Urologie-Muenchen-Germany-C Michael Staehler Germany Bayern Muenchen
142 VITURO, Ges.f. klinische Studien, Ur-Leipzig-Germany-C Detlef Nietzsch Germany Sachsen Leipzig
143 University Hospital of Patras-Patra-Greece-C Haralabos Kalofonos Greece Rio-Patras Rio-Patras
144 University Hospital of Heraklion-Heraklion, Crete-Greece-C Vassilis Georgoulias Greece Heraklion, Crete Heraklion, Crete
145 General Hospital of Athens Aristotelis Bamias Greece Athens Athens
146 Agios Savvas Hospital-Athens-Greece-C Anastasios Thanos Greece Athens Athens
147 Euromedica General Clinic of Thessaloniki-Thessaloniki-Greece-C