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出境医 / 临床实验 / Enzalutamide用于非转移去势难治前列腺癌患者的安全有效性研究
Enzalutamide用于非转移去势难治前列腺癌患者的安全有效性研究
基本信息
| 登记号 | CTR20140772 | 试验状态 | 进行中 |
|---|---|---|---|
| 申请人联系人 | 武晓倩 | 首次公示信息日期 | 2014-11-20 |
| 申请人名称 | Medivation, Inc./ Catalent Pharma Solutions LLC/ 安斯泰来制药（中国）有限公司 | ||
公示的试验信息
一、题目和背景信息
| 登记号 | CTR20140772 | ||
|---|---|---|---|
| 相关登记号 | |||
| 药物名称 | MDV3100胶囊 | ||
| 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 | 前列腺癌 | ||
| 试验专业题目 | Enzalutamide用于非转移去势难治前列腺癌患者的随机、双盲、安慰剂对照国际多中心III期有效安全性研究（PROSPER） | ||
| 试验通俗题目 | Enzalutamide用于非转移去势难治前列腺癌患者的安全有效性研究 | ||
| 试验方案编号 | MDV3100-14 | 方案最新版本号 | 5.0 |
| 版本日期: | 2018-01-26 | 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
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|---|---|---|---|---|---|
| 联系人姓名 | 武晓倩 | 联系人座机 | 021-24227859 | 联系人手机号 | |
| 联系人Email | Xiaoqian.wu@quintiles.com | 联系人邮政地址 | 广东省-广州市-越秀区环市东路339号广东国际大厦主楼7楼720室 | 联系人邮编 | 510098 |
三、临床试验信息
1、试验目的
试验通过评估无转移生存期（MFS）以确定MDV3100与安慰剂相比的有效性，并评价其在非转移性去势难治性前列腺癌患者中的获益及安全性。
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 N/A岁(最大年龄) | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 性别 | 男 | ||||||||||||||||||||||||||||||
| 健康受试者 | 无 | ||||||||||||||||||||||||||||||
| 入选标准 |
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| 排除标准 |
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4、试验分组
| 试验药 |
|
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|---|---|---|---|---|---|---|---|
| 对照药 |
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5、终点指标
| 主要终点指标及评价时间 |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 次要终点指标及评价时间 |
|
6、数据安全监查委员会（DMC）
有
7、是否购买保险
有
四、研究者信息
1、主要研究者信息
| 1 | 姓名 | 邹青 | 学位 | 学士 | 职称 | 主任医师 |
|---|---|---|---|---|---|---|
| 电话 | 13905173337 | zouqingwr@sina.com | 邮政地址 | 江苏省-南京市-玄武区百子亭42号 | ||
| 邮编 | 210009 | 单位名称 | 江苏省肿瘤医院 | |||
2、各参加机构信息
| 序号 | 机构名称 | 主要研究者 | 国家或地区 | 省（州） | 城市 |
|---|---|---|---|---|---|
| 1 | 江苏省肿瘤医院 | 邹青 | 中国 | 江苏省 | 南京市 |
| 2 | 南京大学医学院附属鼓楼医院 | 郭宏骞 | 中国 | 江苏省 | 南京市 |
| 3 | 北京协和医院 | 李汉忠 | 中国 | 北京市 | 北京市 |
| 4 | 卫生部北京医院 | 王建业 | 中国 | 北京市 | 北京市 |
| 5 | 上海市第一人民医院 | 夏术阶 | 中国 | 上海市 | 上海市 |
| 6 | 北京大学第一医院 | 金杰 | 中国 | 北京市 | 北京市 |
| 7 | 苏州大学附属第二医院 | 薛波新 | 中国 | 江苏省 | 苏州市 |
| 8 | 浙江大学医学院附属第二医院 | 杜传军 | 中国 | 浙江省 | 杭州市 |
| 9 | 西安交通大学医学院第一附属医院 | 贺大林 | 中国 | 陕西省 | 西安市 |
| 10 | 北京大学第三医院 | 马潞林 | 中国 | 北京市 | 北京市 |
| 11 | 上海交通大学医学院附属新华医院 | 齐隽 | 中国 | 上海市 | 上海市 |
| 12 | 复旦大学附属华山医院 | 姜昊文 | 中国 | 上海市 | 上海市 |
| 13 | 北京肿瘤医院 | 杨勇 | 中国 | 北京市 | 北京市 |
| 14 | 复旦大学附属肿瘤医院 | 叶定伟 | 中国 | 上海市 | 上海市 |
| 15 | 上海长海医院 | 周铁 | 中国 | 上海市 | 上海市 |
| 16 | Cancer Centers of North Carolina | William Berry | USA | North Carolina | Raleigh |
| 17 | GU Research Network， LLC | Luke Nordquist | USA | Nebraska | Omaha |
| 18 | Carolina Urologic Research Center | Neal Shore | USA | South Carolina | Myrtle Beach |
| 19 | Oregon Urology Institute | Bryan Mehlhaff | USA | Oregon | Springfield |
| 20 | Princess Margaret Hospital | Neil E Fleshner | Canada | Ontario | Toronto |
| 21 | CHUQ-Hotel-Dieu de Quebec and CRCEO | Louis Lacombe | Canada | Quebec | Quebec City |
| 22 | Cross Cancer Institute | Peter Venner | Canada | AB | Edmonton |
| 23 | Centre Hospitalier de l'Université de Montreal | Fred Saad | Canada | Quebec | Montreal |
| 24 | London Regional Cancer Program， London Health Sciences Centre | Eric Winquist | Canada | Ontario | London |
| 25 | Urology South Shore Research | Lorne Aaron | Canada | Quebec | Greenfield Park |
| 26 | Urology Associates/Urologic Medical Research | Russell Egerdie | Canada | Ontario | Kitchener |
| 27 | University of Michigan Comprehensive Cancer Center | Maha Hussain | USA | Michigan | Ann Arbor |
| 28 | Southwest Urology LLC | Lawrence Gervasi | USA | Ohio | Middleburg Heights |
| 29 | Michigan Institute of Urology | Kenneth Kernen | USA | Michigan | Troy |
| 30 | Medizinische Universit？t Wien | Michael Krainer | Austria | Vienna | Wien |
| 31 | Krankenhaus der Barmherzigen Schwestern Linz | Wolfgang Loidl | Austria | Upper Austria | Linz |
| 32 | AZ Groeninge Campus Sint Maarten | Patrick Werbrouck | Belgium | Kortrijk | Kortrijk |
| 33 | University Hospital Gasthuisberg | Hendrik Van Poppel | Belgium | Leuven | Leuven |
| 34 | University Hospital of Liege | David Waltregny | Belgium | Liège | Liège |
| 35 | AZ Maria Middelares | Filip Ameye | Belgium | Gent | Gent |
| 36 | General Hospital of Athens Alexandra | Eleni Efstathiou | Greece | Athens | Athens |
| 37 | University General Hospital of Larissa | Christos Papandreou | Greece | Thessaly | Larissa |
| 38 | General Hospital of Athens Korgialeneio Benakeio | Iraklis Poulias | Greece | ATTIKI | Athens |
| 39 | General Hospital Papageorgiou | Ioannidis Evangelos | Greece | Thessaloniki | Thessaloniki |
| 40 | Institut Gustave Roussy | Karim Fizazi | France | Villejuif | Villejuif |
| 41 | Centre Leon Berard | Aude Flechon | France | Rhone | Lyon |
| 42 | Institut de Cancérologie de l’Quest Site René Gauducheau | Emmanuelle Bompas | France | Loire Atlantique | Saint-Herblain Cedex |
| 43 | Centre Jean Bernard - Clinique Victor Hugo | Eric Voog | France | Le Mans | Le Mans |
| 44 | Institut de Cancérologie de l'Ouest Paul Papin | Philippe Beuzeboc | France | Paris | Paris |
| 45 | CHU Poitiers Hopital la Miletrie | Remy Delva | France | Angers Cedex 9 | Angers Cedex 9 |
| 46 | Institut Bergonié | Jean-Marc Tourani | France | Poitiers | Poitiers |
| 47 | Centre Hospitalier Lyon Sud | Guilhem Roubaud | France | Bordeaux | Bordeaux |
| 48 | Groupement hospitalier Edouard Herriot - Pavillon V | Marc Colombel | France | Lyon Cedex 3 | Lyon Cedex 3 |
| 49 | Rigshospitalet | Peter Iversen | Denmark | Copenhagen | Copenhagen |
| 50 | Herlev Hospital | Per Rathenborg | Denmark | Herlev | Herlev |
| 51 | Arhus Universitetshospital | Michael Borre | Denmark | Aarhus | Aarhus |
| 52 | Tampereen Yliopistollinen Sairaala | Teuvo Tammela | Finland | Tampere | Tampere |
| 53 | Oulun Yliopistollinen Sairaala | Markku Vaarala | Finland | Oulu | Oulu |
| 54 | Helsinki University Hospital | Kimmo Taari | Finland | Helsinki | Helsinki |
| 55 | Satakunnan keskussairaala | Antti Kaipia | Finland | Pori | Pori |
| 56 | Azienda Ospedaliera San Camillo Forlanini | Cora Sternberg | Italy | Roma | Roma |
| 57 | SCDU Oncologia Medica II Pad, AOU San Luigi Gonzaga | Giorgio Scagliotti | Italy | Orbassano | Orbassano |
| 58 | Azienda Ospedaliera Istituti Ospitalieri di Cremona | Rodolfo Passalacqua | Italy | Cremona | Cremona |
| 59 | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Ugo De Giorgi | Italy | Meldola | Meldola |
| 60 | Ospedale Santa Chiara | Orazio Caffo | Italy | Trento | Trento |
| 61 | Fondazione IRCCS Istituto Nazionale dei Tumori | Giuseppe Procopio | Italy | Milano | Milano |
| 62 | Azienda Unità Sanitaria Locale- Ravenna | Giorgio Cruciani | Italy | Ravenna | Ravenna |
| 63 | Catharina Ziekenhuis | Michael de Wildt | Netherlands | Noord-Brabant | Eindhoven |
| 64 | Maastricht University Medical Center | Cees van de Beek | Netherlands | Maastricht | Maastricht |
| 65 | Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka | Jacek Olubiec | Poland | Slupsk | Slupsk |
| 66 | Uniwersyteckie Centrum Kliniczne | Jacek Jassem | Poland | Gdansk | Gdansk |
| 67 | Lexmedia | Zenona Jablonska | Poland | Wroclaw | Wroclaw |
| 68 | Corporació Sanitaria Parc Taulí | Enrique Gallardo | Spain | Cataluna | Sabadell |
| 69 | Hospital Clinic i Provincial de Barcelona | Antonio Alcaraz | Spain | Cataluna | Barcelona |
| 70 | Althaia Xarxa Assistencial | Montserrat Doménech | Spain | Cataluna | Manresa |
| 71 | Complejo Hospitalario de Navarra | Nuria Lainez Milagro | Spain | Navarra | Pamplona |
| 72 | Royal Marsden Hospital | Gerthard Attard | United Kingdom | Sutton | Sutton |
| 73 | The Christie Hospital | Anthony Elliott | United Kingdom | Manchester | Manchester |
| 74 | University College London Hospital | Heather Payne | United Kingdom | London | London |
| 75 | Northern Ireland Cancer Trials Centre | Suneil Jain | Ireland | Belfast | Belfast |
| 76 | Addenbrooke's Hospital | Danish Mazhar | United Kingdom | Cambridgeshire | Cambridge |
| 77 | The Newcastle upon Tyne Hospitals NHS Foundation Trust | Ian Pedley | United Kingdom | Tyne and Wear | Newcastle Upon Tyne |
| 78 | Royal Marsden Foundation Trust | Gerthard Attard | United Kingdom | London | London |
| 79 | Univerztina Nemocnica Martin | Jan Kliment | Slovakia | Martin | Martin |
| 80 | Fakultna Nemocnica S Poliklinikou F.D. Roosevelta | Vladimir Balaz | Slovakia | Banska Bystrica | Banska Bystrica |
| 81 | CUIMED | Frederico M. Goncalves | Slovakia | Bratislava | Bratislava |
| 82 | MILAB s.r.o., UROCENTRUM | Ivan Mincik | Slovakia | Presov | Presov |
| 83 | Uroexam Spol. S r.o. | Jozef Marko | Slovakia | Nitra | Nitra |
| 84 | Vychodoslovensky onkologicky ustav, a.s. | Pavol Dubinsky | Slovakia | Kosice | Kosice |
| 85 | Fakultna Nemocnina s Poliklinikou Skalica a.s. | Jozef Marencak | Slovakia | Skalica | Skalica |
| 86 | Clinical Center Bezanijska Kosa | Vidosav Colovic | Serbia & Montenegro | Belgrade | Belgrade |
| 87 | Clinical Center Dr Dragisa Misovic-Dedinje | Vinka Vukotic | Serbia & Montenegro | Belgrade | Belgrade |
| 88 | Clinical Center Zemun | Bora Cvetkovic | Serbia & Montenegro | Belgrade | Belgrade |
| 89 | Skanes Universitetssjukhus/Malmo | Anders Bjartell | Sweden | Malmo | Malmo |
| 90 | iversitetssjukhuset i Orebro | Ove Andren | Sweden | Orebro | Orebro |
| 91 | Urologmottagningen Sahlgrenska Universitetssjukhuset | Jan-Erik Damber | Sweden | Goteborg | Goteborg |
| 92 | Karolinska Universitessjukhuset Solna | Mats Olsson | Sweden | Stockholm | Stockholm |
| 93 | N.N. Blokhin Russian Cancer Research Center | Vsevolod Matveev | Russia | Moscow | Moscow |
| 94 | First Pavlov State Medical University of St. Petersburg | Salman Kh. Al-Shukri | Russia | Sain-Petersburg | Sain-Petersburg |
| 95 | Saint-Petersburg clinical scientific and practical center | Andrey Novikov | Russia | Sain-Petersburg | Sain-Petersburg |
| 96 | P.A. Gertsen Cancer Research Institute | Boris Alexseev | Russia | Moscow | Moscow |
| 97 | Icon Cancer Care/Mater | Paul Mainwaring | Australia | QLD | South Brisbane |
| 98 | The Tweed Hospital | Ehtesham Abdi | Australia | NSW | Tweed Heads |
| 99 | Port Macquarie Base Hospital | Stephen Begbie | Australia | VIC | Heidelberg |
| 100 | Austin Health | Andrew Weickhardt | Australia | NSW | Westmead |
| 101 | Westmead Hospital | Howard Gurney | Australia | NSW | Concord |
| 102 | Sydney Cancer Centre | Martin Stockler | Australia | VIC | Footscray |
| 103 | Western Hospital | Shirley Wong | Australia | NSW | Wahroonga |
| 104 | Sydney Adventist Hospital | Gavin Marx | Australia | VIC | Box Hill |
| 105 | Box Hill Hospital | Ian Davis | Australia | SA | Kurralta Park |
| 106 | Ashford Cancer Centre Research | Francis Parnis | Australia | VIC | Bentleigh East |
| 107 | Monash Medical Centre | David Pook | Australia | VIC | Malvern |
| 108 | Cabrini Health Hospital | Jeremy Shapiro | Australia | VIC | East Melbourne |
| 109 | Peter MacCallum Cancer Centre | Guy Toner | Australia | WAHROONGA | WAHROONGA |
| 110 | Australian Clinical Trials | Henry Woo | Australia | NSW | Waratah |
| 111 | Calvary Mater Newcastle Hospital | Antonino Bonaventura | Australia | Lismore | Lismore |
| 112 | Lismore Base Hospital | Adam Boyce | Australia | Garren | Garren |
| 113 | Canberra Hospital | Paul Craft | Australia | Woolloongabba | Woolloongabba |
| 114 | Princess Alexandra Hospital | Elizabeth McCaffrey | Australia | Woolloongabba | Woolloongabba |
| 115 | Border Medical Oncology | Craig Underhill | Australia | VIC | Wodonga |
| 116 | Macquarie University | Howard Gurney | Australia | NSW | North Ryde |
| 117 | Haematology and Oncology Clinics of Australia | Michael Slancar | Australia | QLD | Southport |
| 118 | Tasman Oncology Research Pty Ltd | Andrew Hill | Australia | Queensland | Southport |
| 119 | Christchurch Hospital | Stephen Williams | New Zealand | Christchurch | Christchurch |
| 120 | Auckland City Hospital | Peter Fong | New Zealand | Grafton | Grafton |
| 121 | Palmerston North Hospital | Nikolay Nedev | New Zealand | Manawatu | Palmerston North |
| 122 | National University Hospital | Edmund Chiong | Singapore | Singapore | Singapore |
| 123 | National Cancer Centre Singapore | Ravindran Kanesvaran | Singapore | Singapore | Singapore |
| 124 | Severance Hospital | Young-Deuk Choi | Korea, South | Seoul | Seoul |
| 125 | Asan Medical Center | Choung-Soo Kim | Korea, South | Seoul | Seoul |
| 126 | Samsung Medical Center | Hyun-Moo Lee | Korea, South | Seoul | Seoul |
| 127 | Gangnam Severance hospital | Byung Ha Chung | Korea, South | Seoul | Seoul |
| 128 | Seoul National University Hospital | Cheol Kwak | Korea, South | Seoul | Seoul |
| 129 | The China Medical University Hospital | Hsi-Chin Wu | 中国台湾 | Taichung | Taichung |
| 130 | National Taiwan University Hospital | Yeong-Shiau Pu | 中国台湾 | Taipei | Taipei |
| 131 | Chang Gung Memorial Hospital, Chiayi Branch | Chih-Shou Chen | 中国台湾 | Chiayi County | Chiayi County |
| 132 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Shu-Pin Huang | 中国台湾 | Kaohsiung | Kaohsiung |
| 133 | Chang Gung Medical Fundation, Kaohsiung | Po-Hui Chiang | 中国台湾 | Kaohsiung | Kaohsiung |
| 134 | Taichung Veterans General Hospital | Yen-Chuan Ou | 中国台湾 | Taichung | Taichung |
| 135 | Chi Mei Medical Centre | Kun-Hung Shen | 中国台湾 | Tainan City | Tainan City |
| 136 | Chang Gung Memorial Hospital, Keelung Branch | Chun-Te Wu | 中国台湾 | Keelung City | Keelung City |
| 137 | Chang Gung Memorial Hospital | Yung-Chang Lin | 中国台湾 | Gueishan | Gueishan |
| 138 | Taipei Veterans General Hospital | Hsiao-Jen Chung | 中国台湾 | Taipei | Taipei |
| 139 | Chiang Mai Hospital, Maharaj Nakorn Chiang Mai Hospital | Supon Sriplakich | Thailand | Chiang Mai | Muang |
| 140 | Instituto Oncologico Ltda | Pablo Gonzalez | Chile, Rep. of |
