Baltimore他奎莫德胶囊III期临床试验-他奎莫德治疗转移性，去势难治性前列腺癌的研究
BaltimoreJohn Hopkins Kimmel Cancer Center开展的他奎莫德胶囊III期临床试验信息，需要患者受试者,主要适应症为转移性，去势难治性前列腺癌
| 登记号 | CTR20130169 | 试验状态 | 主动暂停 |
|---|---|---|---|
| 申请人联系人 | 刘颖 | 首次公示信息日期 | 2014-04-28 |
| 申请人名称 | Active Biotech AB/ Apoteket Produktion & Laboratorier AB/ Catalent Germany Schorndorf GmbH/ 北京法马苏提克咨询有限公司 | ||
一、题目和背景信息
| 登记号 | CTR20130169 | ||
|---|---|---|---|
| 相关登记号 | 暂无 | ||
| 药物名称 | 他奎莫德胶囊 | ||
| 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 | 转移性，去势难治性前列腺癌 | ||
| 试验专业题目 | 在转移性，去势难治性前列腺癌患者中进行的一项3期，随机化，双盲，安慰剂对照的他奎莫德研究 | ||
| 试验通俗题目 | 他奎莫德治疗转移性，去势难治性前列腺癌的研究 | ||
| 试验方案编号 | 10TASQ10 | 方案最新版本号 | 暂无 |
| 版本日期: | 暂无 | 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 |
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| 联系人姓名 | 刘颖 | 联系人座机 | +8610 5630 7598 | 联系人手机号 | 暂无 |
| 联系人Email | Yingg.liu@ipsen.com | 联系人邮政地址 | 博福-益普生(天津)制药有限公司，北京市朝阳区曙光西里5号凤凰置地广场H座12层1206 | 联系人邮编 | 100028 |
三、临床试验信息
1、试验目的
此研究的主要目的，是确证他奎莫德与安慰剂比较，在延迟疾病进展或死亡方面的效果。 2、试验设计
| 试验分类 | 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（台湾20）岁(最小年龄)至 无岁(最大年龄) | ||||||||||||||||||||||||||||||||||||||||||
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| 性别 | 男 | ||||||||||||||||||||||||||||||||||||||||||
| 健康受试者 | 无 | ||||||||||||||||||||||||||||||||||||||||||
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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 |
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四、研究者信息
1、主要研究者信息
| 1 | 姓名 | Micheal Carducci, M.D. | 学位 | 暂无 | 职称 | 美国内科医师协会会员 |
|---|---|---|---|---|---|---|
| 电话 | +1 41-614 3977 | Carducci@jhmi.edu | 邮政地址 | 1M59 CRB1 Baltimore, MD 21231 USA | ||
| 邮编 | 1650 | 单位名称 | John Hopkins Kimmel Cancer Center | |||
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 | John Hopkins Kimmel Cancer Center | Michael Carducci | UNITED STATES | NA | Baltimore |
| 2 | 复旦大学附属肿瘤医院 | 叶定伟 | 中国 | 上海 | 上海 |
| 3 | 复旦大学附属华山医院 | 丁强 | 中国 | 上海 | 上海 |
| 4 | 成都军区总医院 | 王亮 | 中国 | 四川 | 成都 |
| 5 | 汕头大学医学院第二附属医院 | 郑俊鸿 | 中国 | 广东 | 汕头 |
| 6 | 武汉大学中南医院国家药物临床试验机构 | 周福祥 | 中国 | 湖北 | 武汉 |
| 7 | 南昌大学附属第一医院 | 王共先 | 中国 | 江西省 | 南昌 |
| 8 | 中国人民解放军第三〇七医院 | 陈立军 | 中国 | 北京 | 北京 |
| 9 | Coffs Harbour Health | Karen Briscoe | AUSTRALIA | NA | Coffs Harbour |
| 10 | Australian Prostate Cancer Research Centre@ Epworth | Anthony Costello | AUSTRALIA | NA | Richmond, VIC |
| 11 | St John of God Hospital | siobhan Ng | AUSTRALIA | NA | Subiaco |
| 12 | St Vincent's Hospital | Richard Epstein | AUSTRALIA | NA | Darlinghurst |
| 13 | Royal Prince Alfred | Lisa Horvath | AUSTRALIA | NA | Camperdown |
| 14 | Cairns Base Hospital | Muhammad Islam | AUSTRALIA | NA | Cairns |
| 15 | Orchid Nursing Home | Gouri Shankar. Bhattacharyya | INDIA | NA | Kolkata |
| 16 | Jehangir Clinical Development Centre | B.D Kashyapi | INDIA | NA | Pune |
| 17 | Monilek Hospital& Research Centre | sunder lal .Tolani | INDIA | NA | Jaipur |
| 18 | Amrita Institute of Medical Sciences | Ginil Kumar | INDIA | NA | Elamakkara |
| 19 | Christian Medical College Hospital | Kim Mammen | INDIA | NA | Ludhiana |
| 20 | Tata Memorial Hospital | Vanita Noronha | INDIA | NA | Maharashtra |
| 21 | Shatabdi Superspeciality Hospital | Shailesh Bondarde | INDIA | NA | Mumbai Naka |
| 22 | Tauranga Urology Research Ltd | Peter Gilling | NEW ZEALAND | NA | Tauranga |
| 23 | Cardinal Points Specialist Centre | Anthony Nixon | NEW ZEALAND | NA | Whangarei |
| 24 | CURT Medical Trials Trust Board Inc. | Frank Kueppers | NEW ZEALAND | NA | Christchurch |
| 25 | Roundhay Medical Centre | Patrick Meffan | NEW ZEALAND | NA | Nelson |
| 26 | Palmerston North Hospital | Quinten King | NEW ZEALAND | NA | Palmerston North |
| 27 | Gangnam Severance Hospital | Byung Ha Chung | SOUTH KOREA | NA | Seoul |
| 28 | CHONNAM NATIONAL UNIVERSITY HOSPITAL | TAKE WON KANG | SOUTH KOREA | NA | Gwangju |
| 29 | Seoul St. Mary's Hospital | Sae Woong Kim | SOUTH KOREA | NA | Seoul |
| 30 | Samsung Medical Center | HYUN MOO. LEE | SOUTH KOREA | NA | Seoul |
| 31 | ASAN Medical Centre | Choung-Soo Kim | SOUTH KOREA | NA | Seoul |
| 32 | Severance Hospital, Yonsei University Healthcare system | Hong Sung .Joon | SOUTH KOREA | NA | Seoul |
| 33 | Seoul National University Hospital | Cheol Kwak | SOUTH KOREA | NA | Seoul |
| 34 | Chang Gung Mecical Foundation-Linkou Branch | Cheng-Keng Chuang | 中国 | NA | Taoyuan |
| 35 | Taichung Veterans General Hospital | Yen-Chuan Ou | 中国 | NA | Taichung |
| 36 | National Taiwan University Hospital | Yu-chieh Tsai | 中国 | NA | Taipei |
| 37 | Kaohsiung Veterans General Hospital | Tony Wu | 中国 | NA | Kaohsiung |
| 38 | Centro Oncologico Agave | Natalia Broglia | ARGENTINA | NA | Venado Tuerto (Sta Fe). |
| 39 | IMAI Research | Silvia Carraro | ARGENTINA | NA | C.A.B.A |
| 40 | CDU | Luis. Montes de Oca | ARGENTINA | NA | C.A.B.A |
| 41 | Fundacion Koriza | Pablo Picon | ARGENTINA | NA | Santa Rosa- La Pampa |
| 42 | Hospital Italiano de Buenos Aires | Maria Pallota | ARGENTINA | NA | C.A.B.A |
| 43 | Centro de Pesquisas Clinicas em Oncologia | Sabina Aleixo | BRAZIL | NA | Cachoeiro de Itapemirim |
| 44 | CMIP-CENTRO MINEIRO DE PESQUISA | CHRISTIANE ALVES | BRAZIL | NA | JUIZ DE FORA-MG |
| 45 | Oncotrat Oncologia Medica Ltda | Iane Cardoso | BRAZIL | NA | Rio de Janeiro |
| 46 | LIGA NORTE RIOGRANDENSE CONTRA O CANCER | DANIELLI MATIAS | BRAZIL | NA | NATAL/RN |
| 47 | CEPON | Yeni Veronica. Neron do Nascimento | BRAZIL | NA | Florianopolis |
| 48 | ONCOVIDA | ALBERTO NOGUEIRA | BRAZIL | NA | SALVADOR |
| 49 | Premier Residence Hospital | Roberto. Odebrecht Rocha | BRAZIL | NA | sao paulo |
| 50 | Centro Oncologico de Mogi das Cruzes | Daniel .Grabarz (Dr Rodriguez, Flavio) | BRAZIL | NA | Mogi das Cruzes |
| 51 | Hospital da Cidade de Passo Fundo | Luis Alberto. Schlittler | BRAZIL | NA | Passo Fundo |
| 52 | HCPA | Gilberto Schwartsmann | BRAZIL | NA | Porto Alegre |
| 53 | Rio Sul Centro Pesquisa Clinica | Leonardo Osorio | BRAZIL | NA | Rio de Janeiro |
| 54 | Universidade Estadual Paulista Julio de Mesquita Filho | Guareide Carelli | BRAZIL | NA | Botucatu |
| 55 | Hospital Erasto Gaertner | FLAVIO. SAAVEDRA TOMASICH | BRAZIL | NA | Curitiba |
| 56 | Fundacao Pio XII - Hospital de Cancer de Barretos | Flavio. Mavignier Carcano | BRAZIL | NA | Barretos |
| 57 | ONCOVIDA | Alejandro. Acevedo Gaete | CHILE | NA | VINA DEL MAR |
| 58 | Centro de especialidades medicas | Mario GORENA | CHILE | NA | TEMUCO |
| 59 | UROMED CLINIC | Anibal. Salazar Huerta | CHILE | NA | SANTIAGO |
| 60 | HOSPITAL DIPRECA | Luis .SOTO DIAZ | CHILE | NA | SANTIAGO |
| 61 | HOSCAR | Nelson .Orellana Salinas | CHILE | NA | SANTIAGO |
| 62 | FUNDACION VALLE DEL LILI | Manuel .Duque Galan | COLOMBIA | NA | CALI |
| 63 | FUNDACION SANTA FE | CARLOS VARGAS | COLOMBIA | NA | BOGOTA |
| 64 | CAFAM | LUIS AMADOR | COLOMBIA | NA | BOGOTA |
| 65 | Hospital Angeles Puebla | JOSE. ARROYO KURIBRENA | MEXICO | NA | PUEBLA |
| 66 | HRDEB | Marco. Badillo Santoyo | MEXICO | NA | LEON |
| 67 | CHRISTUS MUGUERZA DEL PARQUE | ROBERTO .HIDALGO-SILVA | MEXICO | NA | CHIHUAHUA CHIHUAHUA |
| 68 | HOSPITAL ANGELES CULIACAN | GUSTAVO GAXIOLA-MEZA | MEXICO | NA | CULIACAN, SINALOA |
| 69 | Hospital Universitario Dr. José Eleuterio Gonzalez Universidad Autonoma de Nuevo Leon | LAURO .GOMEZ GUERRA | MEXICO | NA | Monterrey |
| 70 | PRIVATE OFFICE | JOSE ARTURO .RODRIGUEZ RIVERA | MEXICO | NA | ZAPOPAN |
| 71 | Centro Hemato Oncologico | Juan Pablo .Bares Weeden | PANAMA | NA | Panama |
| 72 | Clinica San Fernando | Javier. Del Rosario Gibbs | PANAMA | NA | Panama |
| 73 | Medical Reaserch Center | Roberto LOPEZ | PANAMA | NA | Panama |
| 74 | Caja de Seguro Social Hospital metropolitano | Alejandro Manduley | PANAMA | NA | Panama |
| 75 | Servicio de Medicina Oncologica - Hospital Goyeneche | Ernesto. Andres Vargas Quesada | PERU | NA | Arequipa - PERU |
| 76 | HOSPITAL CASE AREQUIPA | David .Moron Escobar | PERU | NA | Arequipa |
| 77 | CHU Liege | Brieuc Sautois | BELGIUM | NA | LIEGE |
| 78 | AZ Groeninge Kortrijk | Patrick Werbrouck | BELGIUM | NA | Kortrijk |
| 79 | ULB Erasme Hospital | Th. Roumeguere | BELGIUM | NA | Brussels |
| 80 | AZ Maria Middelares | Filip Ameye | BELGIUM | NA | Gent |
| 81 | District dispensary for oncolog. diseases with inpatient unit-sofia sity | Borislav Dimitrov | BULGARIA | NA | sofia |
| 82 | Interdistrict Dispensary for Oncology Diseases with Inpatient Sector – Ruse Chemotherapy Department | Katerina Guenova | BULGARIA | NA | Rousse |
| 83 | MHAT Sveta Marina – Varna | Dimitar Kalev | BULGARIA | NA | Varna |
| 84 | District Dispensary for Oncology Diseases with Inpatient Unit-Plovdiv, Second Internal Department | Petar Petrov | BULGARIA | NA | Plovdiv |
| 85 | Interdistrict Dispensary for Oncology Diseases with Inpatient Unit “Dr. Marko Antonov Markov” - Varna Department of Medical Oncotherapy and Palliative Care | Violina Taskova | BULGARIA | NA | Varna |
| 86 | University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL Clinic of Oncotherapy | Assen Dudov | BULGARIA | NA | Sofia |
| 87 | UMHAT D-r Georgi Stranski | Rumyana Micheva | BULGARIA | NA | Pleven |
| 88 | Kromerizska nemocnice a.s. | Lumir Domes | CZECH REPUBLIC | NA | Kromeriz |
| 89 | Department of Urology, Hospital Motol | Josef Stolz | CZECH REPUBLIC | NA | Praha 5 |
| 90 | Urocentrum Praha | Michaela Matouskova | CZECH REPUBLIC | NA | Praha 2 |
| 91 | Department of Urology, Masaryk hospital Usti nad Labem | Jan Schram | CZECH REPUBLIC | NA | Usti nad Labem |
| 92 | Department of Urology, Hospital Novy Jicin | Miroslav Stursa | CZECH REPUBLIC | NA | Novy Jicin |
| 93 | Urology Clinics of the Faculty Hospital Olomouc | Vladimir STUDENT | Czech Republic | NA | Olomouc |
| 94 | Tartu University Hospital, Surgery Clinic, Dep. of urology and renal transplantation | Kahu Jaanus | ESTONIA | NA | Tartu |
| 95 | East Tallinn Central Hospital, Surgery Clinic, Department of Urology | Tamm Toomas | ESTONIA | NA | Tallinn |
| 96 | Cannes hospital | Regis Kaphan | FRANCE | NA | Cannes |
| 97 | CHU Lapeyronie | Xavier Rebillard | France | NA | Montpellier |
| 98 | Hopital Foch | Christine Theodore | France | NA | Suresnes |
| 99 | Centre Regional de lutte contre le cancer Paul Papin | Remy Delva | France | NA | Angers |
| 100 | Centre hospitalier Lyon Sud | Alain RUFFION | France | NA | PIERRE-BENITE |
| 101 | CRLC Val d'Aurelle | David Azria | France | NA | Montpellier |
| 102 | N.H.C. H.U.S. | Didier Jacqmin | France | NA | Strasbourg |
| 103 | Centre Eugene Marquis | Vincent VINCENDEAU-RECOQUILLON | France | NA | RENNES |
| 104 | Institut Curie | Philippe Beuzeboc | France | NA | Paris |
| 105 | Paris at Saint-Louis Hospital | Stephane Culine | France | NA | Creteil |
| 106 | Hopsital Nord | Marjorie BACIUCHKA-PALMARO | France | NA | Marseille |
| 107 | CHU de la Timone | Jean Laurent. DEVILLE | France | NA | Marseille |
| 108 | Universitatsklinik fur Urologie | Arnulf Stenzl | GERMANY | NA | Tubingen |
| 109 | Urologische Studienpraxis | Susan Feyerabend | GERMANY | NA | Nurtingen |
| 110 | Universitatsklinikum Munster. Klinik und Polikklinik fur Urologie | Martin Bogemann | GERMANY | NA | Munster |
| 111 | Kliniken Nordoberpfalz AG, Klinikum Weiden | Theodor klotz | GERMANY | NA | Weiden |
| 112 | Klinik fur Urologie und Kinderurologie, Universitatsklinikum Gieβen und Marburg GmbH | Axel Hegele | GERMANY | NA | Marburg |
| 113 | Universitatsklinikum Koln, Klinik und Poliklinik fur Urologie | Sebastian Wille | GERMANY | NA | Cologne |
| 114 | University of Munich, Dept. of urology | Patrick Bastian | GERMANY | NA | Munich |
| 115 | Department of Urology | Manfred Wirth | GERMANY | NA | Dresden |
| 116 | Evangelisches Krankenhaus Bielefeld gGmbH Akademisches Lehrkrankenhaus der Universitat | Jesco Pfitzenmaier | GERMANY | NA | Bielefeld |
| 117 | Martini-Clinic, Prostate Cancer Center | Thomas Steuber | GERMANY | NA | Hamburg |
| 118 | Geschaftsfuhrender Oberarzt der Urologischen Klinik Universitasklinikum Mannheim | Christian Bolenz | GERMANY | NA | Mannheim |
| 119 | Alexandra General Hospital of Athens, Department of Clinical Therapeutics | eleni Efstathiou | GREECE | NA | Athens |
| 120 | General Hospital of Athens Korgialenio-Benakio Greek Red Cross, Urology Clinic | Iraklis Poulias | GREECE | NA | Athens |
| 121 | O Agios Savvas Anticancer-Oncology Hospital of Athens, Urology Clinic | ANASTASIOS THANOS | GREECE | NA | Athens |
| 122 | Ippokrateio General Hospital of Thessaloniki, Urology Clinic, | Vasileios Papathanasia | GREECE | NA | Thessaloniki |
| 123 | University Genral Hospital of Patras, Urology Clinic | Petros Perimenis | GREECE | NA | Patras |
| 124 | The Chaim Sheba Medical Center, Oncology Institute | Raanan Berger | ISRAEL | NA | Ramat-Gan |
| 125 | The Lady Davis Carmel Medical Center | Avi Stein | ISRAEL | NA | Haifa |
| 126 | Asaf Harofeh Medical Center, Oncology Department | Avishay Sella | ISRAEL | NA | Zerifin |
| 127 | Tel-Aviv Sourasky Medical Center | Eliahu Gez | ISRAEL | NA | Tel-Aviv |
| 128 | Rambam Medical Center, Oncology Institute | Avivit Peer | ISRAEL | NA | Haifa |
| 129 | Rabin MC, Institute of Oncology, Davidoff Cancer Center | Eli Rozenbaum | ISRAEL | NA | Petach Tikva |
| 130 | Bnai Zion Medical Center | Ofer Nativ | ISRAEL | NA | Haifa |
| 131 | Hadassah Hebrew University medical center | Stephen Frank | ISRAEL | NA | Jerusalem |
| 132 | Soroka University Medical Center | Wilmosh Mermershtain | ISRAEL | NA | Beer Sheva |
| 133 | Azienda Ospedaliera San Camillo Forlanini, Unita Operativa Oncologia Medica | Cora Sternberg | ITALY | NA | Roma |
| 134 | Unita Operativa Oncologia Medica, Gruppo di Patologia Uro-Ginecologica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST | Cecelia | ITALY | NA | Meldola |
| 135 | Istituto Oncologico Veneto, Unita Operativa di Oncologia Medica I | UMBERTO BASSO | ITALY | NA | Padova |
| 136 | Presidio Ospedaliero A. Manzoni, Oncologia Medica | Antonio Ardizzoia | ITALY | NA | Lecco |
| 137 | Oncologia Medica Falck, Azienda Ospedaliera Niguarda Ca Granda Azienda Ospedaliera Niguarda Ca Granda | SALVATORE SIENA | ITALY | NA | MILANO |
| 138 | Unita Operativa di Urologia, ASL 4 di Teramo, Presidio Ospedaliero G. Mazzini | Carlo Vicentini | ITALY | NA | Teramo |
| 139 | Azienda Ospedaliero Universitaria Molinette San Giovanni Battista, S.C. Oncologia Medica 1 | LIBERO CIUFFREDA | ITALY | NA | TORINO |
| 140 | Azienda Ospedaliera Istituti Ospitalieri, Struttura Complessa Oncologia - Dipartimento Oncologico | rodolfo passalacqua | ITALY | NA | cremona |
| 141 | Azienda USL Ravenna | Giorgio Cruciani | ITALY | NA | Ravenna |
| 142 | Azienda Ospedaliera - Ospedale San Carlo Borromeo, Divisione di Oncologia | maria cristina. locatelli | ITALY | NA | Milano |
| 143 | Latgalian Urology Center | Olegs Hublarovs | LATVIA | NA | Daugavpils |
| 144 | Riga Eastern University Hospital | Arija Brize | LATVIA | NA | Riga |
| 145 | Private practice of Dr.Dzintra Litavniece | Dzintra Litavniece | LATVIA | NA | Liepaja |
| 146 | Pauls Stradins Clinical University Hospital | Egils Vjaters | LATVIA | NA | Riga |
| 147 | Middle East Institute of Health | Dany. Abi Gerges | LEBANON | NA | Bsalim |
| 148 | Rafic HARIRI University Hospital | Issam CHEHADE | LEBANON | NA | Beirut |
| 149 | American University of Beirut Medical Center | Ali Shamseddine | LEBANON | NA | Beirut |
| 150 | Vilnius University Hospital Santariskiu Clinics | Feliksas Jankevicius | LITHUANIA | NA | Vilnius |
| 151 | Oncology Institute of Vilnius University, Department of Oncourology | Albertas Ulys | LITHUANIA | NA | Vilnius |
| 152 | Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Daimantas Milonas | LITHUANIA | NA | Kaunas |
| 153 | St. Elisabeth Ziekenhuis | Paul Kil | NETHERLANDS | NA | Tilburg |
| 154 | Martini Ziekenhuis, Polikliniek urologie | Leon Wymenga | NETHERLANDS | NA | Groningen |
| 155 | Canisius-Wilhelmina Ziekenhuis | Henk Vergunst | NETHERLANDS | NA | Nijmegen |
| 156 | LUMC, Medische Oncologie, | Hans Gelderblom | NETHERLANDS | NA | Leiden |
| 157 | Hospital Medic | J. de la Rosette | NETHERLANDS | NA | AMSTERDAM |
| 158 | VUMC | R. Van Moorselaar | NETHERLANDS | NA | Amsterdam |
| 159 | UMC St Radboud Nijmegen | Peter Mulders | Netherlands | NA | Nijmegen |
| 160 | Institute of Oncology | Tomasz Demkow | POLAND | NA | Warszawa |
| 161 | NZOZ Centrum Urologiczne Sp. z o.o. | Adam Dobrowolski | POLAND | NA | Myslowice |
| 162 | Oddzial Chorob Rozrostowych | Ewa Kalinka-Warzocha | POLAND | NA | Lodz |
| 163 | EMC Instytut Medyczny SA | Rafal Kmieciak | POLAND | NA | Wroclaw |
| 164 | SP ZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego | Robert Kozlowski | POLAND | NA | Bialystok |
| 165 | Wielkopolskie Centrum Onkologii | Piotr Milecki | POLAND | NA | Poznan |
| 166 | Niepubliczny Zaklad Opieki Zdrowotnej Avimed Sp. z o.o. | Kamil Bochynek | POLAND | NA | Katowice |
| 167 | LexMedica | Zenona Jablonska | POLAND | NA | Wroclaw |
| 168 | Oddzial Wewnetrzny III ze Stacja Dializ; Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej | Przemyslaw WIERZBICKI | POLAND | NA | Wolomin |
| 169 | SC Oncolab SRL | Dan Lungulescu | ROMANIA | NA | Craiova |
| 170 | Fundeni Clinical Institute, Urology Department | Mihai Harza | ROMANIA | NA | Bucharest |
| 171 | County Emergency Hospital Sf.Ioan cel Nou | Doina Elena . Ganea | ROMANIA | NA | Suceava |
| 172 | Institute of Oncology Prof. Dr. Ion Chiricuta, Oncology Department | Cristina Ligia . Cebotaru | ROMANIA | NA | Cluj-Napoca |
| 173 | Institute of Oncology Prof. Dr. Ion Chiricuta, Oncology Department | Tudor Eliade. Ciuleanu | ROMANIA | NA | Cluj Napoca |
| 174 | Baia Mare, Emergency County Hospital Dr. Constantin Opris | Dumitru Filip | ROMANIA | NA | BAIA MARE |
| 175 | ONCOMED, Medical Oncology | CRISTINA OPREAN | ROMANIA | NA | TIMISOARA |
| 176 | PROVITA 2000 Medical Center, Urology Department | Laurentiu Babu | ROMANIA | NA | Constanta |
| 177 | Ianuli Medconsult SRL, Medical Oncologym Ground Floor, ap. 1 | Carmen Ianuli | ROMANIA | NA | Bucharest |
| 178 | County Hospital | Daniel Iacob | ROMANIA | NA | BRASOV |
| 179 | County Hospital | Gabriel Doru. Ghizdavescu | ROMANIA | NA | PLOIESTI |
| 180 | Clinical Oncology Dispensary, Oncourology Department | Evgeniy Kopyltsov | RUSSIA | NA | Omsk |
| 181 | Altay Regional Oncology Center | Vladimir Lubennikov | RUSSIA | NA | Barnaul |
| 182 | Clinic Andros LLC, Urology Department | Alexey Plekhanov | RUSSIA | NA | Saint-Petersburg |
| 183 | Leningrad Regional Oncological Dispansery | Khvorostenko | RUSSIA | NA | Saint-Petersburg |
| 184 | City Hospital #15, Urology Department, Floor 2 | Vakhtang Shanava | RUSSIA | NA | Saint-Petersburg |
| 185 | Republic Clinical Oncology Center, Chemotherapy Department | Sergey Emelyanov | RUSSIA | NA | Izhevsk |
| 186 | Regional Clinical Oncology Center | Natalia Rodicheva | RUSSIA | NA | Vladimir |
| 187 | Hospital OrKli, Urology Department, Office 20 H | Vladimir Kheifets | RUSSIA | NA | St.Petersburg |
| 188 | St.Petersburg Multi-Field City Hospital #2, Department of Urology, 8 floor | Boris Komyakov | RUSSIA | NA | St. Petersburg |
| 189 | Russian Oncology Research Center named after N.N. Blokhin, Department of Clinical Pharmacology and Chemotherapy, 22-floor Office #2207 | Avgust Mikhaylovich .Garin | RUSSIA | NA | Moscow |
| 190 | Moscow Hertzen Oncology Institute | Boris Alekseev | RUSSIA | NA | Moscow |
| 191 | Sverdlovsk Regional Hospital #1 | Alexander Zyirianov | RUSSIA | NA | Ekaterinburg |
| 192 | LLC Medical Center Reafan | Marat Zaripov | RUSSIA | NA | Novosibirsk |
| 193 | Privatna Urologicka Ambulancia | Roman Sokol | SLOVAKIA | NA | Trencin |
| 194 | CUIMED, s.r.o., Urologicka ambulancia | Frederico Goncalves | SLOVAKIA | NA | Bratislava |
| 195 | Hospital Clinic i Provincial | begona mellado | SPAIN | NA | Barcelona |
| 196 | Corporacio Sanitaria Parc Tauli | Enrique Gallardo | SPAIN | NA | Sabadell |
| 197 | Hospital Infanta Sofia | Emilio Rios | SPAIN | NA | San Sebastian de los Reyes |
| 198 | Clinica Universitaria de Navarra | JOSE LUIS. PEREZ Gracia | SPAIN | NA | PAMPLONA |
| 199 | Hospital Universitario Virgen de la Arrixaca | Isabel. de la Fuente Munoz | SPAIN | NA | El Palmar |
| 200 | Hospital Virgen del Rocio | Begona. Perez-Valderrama | SPAIN | NA | Sevilla |
| 201 | Hospital Clinico Universitario de Valencia | Isabel Chirivella | SPAIN | NA | Valenica |
| 202 | Hospital Universitario Marques de Valdecilla | marta. lopez-brea piqueras | SPAIN | NA | Santander |
| 203 | Hospital Vall D′Hebron | Joan CARLES | SPAIN | NA | Barcelona |
| 204 | Hospital de la Santa Creu i Sant Pau | Pablo Maroto | SPAIN | NA | Barcelona |
| 205 | Hospital Universitario Fundacion Alcorcon | Jesus Garcia-Donas | SPAIN | NA | Alcorcon |
| 206 | HCULB | A Saez | Spain | NA | Zaragoza |
| 207 | Hospital Universitatario Central de Asturias | Enrique Estrada | Spain | NA | OVIEDO |
| 208 | IVO | Eduardo. Solsona Narbona | Spain | NA | Valencia |
| 209 | Karolinska Hospital | Sten Nilsson | SWEDEN | NA | Stockholm |
| 210 | Urologiska Kliniken | Jan-Erik Damber | SWEDEN | NA | Goteborg |
| 211 | Oncology clinic | Claes Ginman | SWEDEN | NA | Karlstad |
| 212 | Gazi University Medical Faculty Gazi Hospital | Mustafa Benekli | TURKEY | NA | Ankara |
| 213 | Selcuk University Medical Faculty | Serdar Goktas | TURKEY | NA | KONYA |
| 214 | Cukurova University Medical Faculty Balcali Hospital | Berksoy Sahin | TURKEY | NA | Adana |
| 215 | Istanbul University Cerrahpa？a Medical Faculty Urolgy Department | Obek Can | TURKEY | NA | Istanbul |
| 216 | Kharkiv Regional Clinical Center of Urology and Nephrology, Department of Urology #4 | Igor Antonyan | UKRAINE | NA | Kharkiv |
| 217 | Ivano-Frankivsk Regional Oncological Dispensary, Oncology Department | Ipolit Kostinskyy | UKRAINE | NA | Ivano-Frankivsk |
| 218 | Dnipropetrovsk State Medical Academy, Oncology, Radiodiagnostic and Radiotherapy Chair, City Clinical Hospital #4, 9th Floor | Igor Bondarenko | UKRAINE | NA | Dnipropetrovsk |
| 219 | Zaporizhzhya Medical Academy of Postgraduate Education, Urology Dept | Olexiy Lyulko | UKRAINE | NA | Zaporozhye |
| 220 | Donetsk Regional Clinical Territorial Medical Association, Department of Urology | Valentyn Kobets | UKRAINE | NA | Donetsk |
| 221 | Kyiv City Clinical Hospital #3, Urology Dept. | Petro Ivashchenko | UKRAINE | NA | Kyiv |
| 222 | Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov, Urology Department # 2 | Viktor Stus | UKRAINE | NA | Dnepropetrovsk |
| 223 | Bukovinian State Medical University | Valerii Zaitsev | UKRAINE | NA | Chernivtsi |
| 224 | State Institution of Healthcare, Urology Dept. #3, Kyiv Oleksandrivska Clinical Hospital | Sergii Pasiechnikov | UKRAINE | NA | Kyiv |
| 225 | Uzhgorod Central Municipal Clinical Hospital, Municipal Oncological Center | Yevhen Hotko | UKRAINE | NA | Uzhgorod |
| 226 | Donetsk Regional Antineoplastic Center, Department of Urology #2 | Andriy Anishchenko | UKRAINE | NA | Donetsk |
| 227 | Crimea State Medical University n.a. S. I. Georgievsky, Chair of Oncology | Vitaliy Seferov | UKRAINE | NA | Simferopo |
| 228 | Volyn Regional Oncology Dispensary | Orest Andrusenko | UKRAINE | NA | Lutsk |
| 229 | State Regional Diagnostics and Treatment Oncology Center | Yaroslav Shparyk | UKRAINE | NA | Lvov |
| 230 | Donetsk City Clinical Hospital # 1 | Yuriy Sernyack | UKRAINE | NA | Donetsk |
| 231 | Kyiv Regional Clinical Oncology Dispensary, Oncourology department | Golovko | UKRAINE | NA | Kyiv |
| 232 | Odesa Regional Clinical Oncology dispensary, Chemotherapy department | Natalya Tavartkiladze | UKRAINE | NA | Odesa |
| 233 | Leeds NHS Trust | William Cross | UNITED KINGDOM | NA | Leeds |
| 234 | Royal Marsden Hospital | Robert huddart | UNITED KINGDOM | NA | Sutton |
| 235 | Mount Vernon Hospital | Peter Hoskin | UNITED KINGDOM | NA | Northwood |
| 236 | Oxford Cancer and Haematology Centre | andrew Protheroe | UNITED KINGDOM | NA | Oxford |
| 237 | St Richard's Hospital, Dept. of Urology | Paul Carter | UNITED KINGDOM | NA | West Sussex |
| 238 | North Lincolnshire & Goole NHS Trust, Scunthorpe General Hospital | Sanjay Dixit | UNITED KINGDOM | NA | Scunthorpe |
| 239 | Sarah Cannon Research UK | Simon Chowdhury | UNITED KINGDOM | NA | LONDON |
| 240 | University Hospital Birmingham | Nicholas James | UNITED KINGDOM | NA | Birmingham |
| 241 | Nottingham City | Santhanam Sundar | UNITED KINGDOM | NA | Nottingham |
| 242 | Urology Center of Alabama, PC | George Adams | UNITED STATES | NA | Homewood |
| 243 | Huntsman Cancer Institute, University of Utah | Neeraj Agarwal | UNITED STATES | NA | Salt Lake City |
| 244 | Associates in Oncology/Hematology, PC | Manish Agrawal | UNITED STATES | NA | Rockville |
| 245 | John Theurer Cancer Center at Hackensack University Medical Center | Robert Alter | UNITED STATES | NA | Hackensack |
| 246 | Andreou Research | Cal Andreou | CANADA | NA | Surrey |
| 247 | Duke Ubniversity Medical Center | Andrew Armstrong | UNITED STATES | NA | Durham |
| 248 | Peachtree Hematology-Oncology Consultants | Vasileios Assikis | UNITED STATES | NA | Atlanta |
| 249 | Metropolitan Urology, PSC | James Bailen | UNITED STATES | NA | Jeffersonville |
| 250 | Newport Pacific Medical Associates Inc. | Neil Barth | UNITED STATES | NA | Newport Beach |
| 251 | Urologic Consultants of SE PA | Laurence Belkoff | UNITED STATES | NA | Bala Cynwyd |
| 252 | Raleigh Hematology Oncology Associates, P.C. | William Berry | UNITED STATES | NA | Raleigh |
| 253 | Pacific Clinical Center | Stanley Brosman | UNITED STATES | NA | Santa Monica |
| 254 | The Female/Male Health Centres | Richard Casey | CANADA | NA | Oakville |
| 255 | Willamette Valley Cancer Institute and Research Center | John R. Caton | UNITED STATES | NA | Springfield |
| 256 | Vanderbilt University Medical Center, Dept. of Urologic Surgery | Sam Chang | UNITED STATES | NA | Nashville |
| 257 | PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists | Kevin Chang | UNITED STATES | NA | Oxnard |
| 258 | Mid Ohio Oncology/ Hematology, Inc., DBA | Tarek Chidiac | UNITED STATES | NA | Columbus |
| 259 | North Idaho Urology | Randil Clark | UNITED STATES | NA | Couer D'Alene |
| 260 | Alaska Clinical Research Center, LLC | William R. Clark | UNITED STATES | NA | Anchorage |
| 261 | Urology Clinics of North Texas, PA | James Cochran | UNITED STATES | NA | Dallas |
| 262 | Arizona Oncology Associates | Christopher DiSimone | UNITED STATES | NA | Tucson |
| 263 | The Urological Institute of Northeast New York, CCP | Hugh Fisher | UNITED STATES | NA | Albany |
| 264 | Stanley Flax Medical Professional Corporation | Stanley Flax | CANADA | NA | North York |
| 265 | Virginia Oncology Associates | Mark Fleming | UNITED STATES | NA | Norfolk |
| 266 | Seattle Urology Research Center | Jeffrey Frankel | UNITED STATES | NA | Burien |
| 267 | University of Pittsburgh Dept of Urology | Jeff Gingrich | UNITED STATES | NA | Pittsburgh |
| 268 | Hudson Valley Urology | Evan Goldfischer | UNITED STATES | NA | Poughkeepsie |
| 269 | South Orange County Medical Research Center | Richard Greengold | UNITED STATES | NA | Laguna Hills |
| 270 | Midwest Urology/RMD Clinical Research | Richard Harris | UNITED STATES | NA | Melrose Park |
| 271 | Texas Oncology Cancer Center-Round Rock | Beth Hellerstedt | UNITED STATES | NA | Round Rock |
| 272 | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Thomas Hutson | UNITED STATES | NA | Dallas |
| 273 | Lawrenceville Urology | Gary Karlin | UNITED STATES | NA | Lawrenceville |
| 274 | Urological Physicians of S.D. | Danny Keiller | UNITED STATES | NA | San Diego |
| 275 | Capitol Comprehensive Cancer Care Clinic | Ali Khojasteh | UNITED STATES | NA | Jefferson City |
| 276 | Southern Interior Medical Research Inc. | Thomas Kinahan | CANADA | NA | Kelowna |
| 277 | Oncology and Hematology Associates of Southwest Virginia, Inc., DBA | Mark Kochenderfer | UNITED STATES | NA | Salem |
| 278 | Redwood Regional Medical Group | Wes Lee | UNITED STATES | NA | Santa Rosa |
| 279 | Brantford Urology Research | Wilson Leung | CANADA | NA | Brantford |
| 280 | Hamilton Urology PA | Earle Linder | UNITED STATES | NA | Hamilton |
| 281 | Northeast Urology Research | David Lipsitz | UNITED STATES | NA | Concord |
| 282 | Mor Urology, Inc. | Morrie Liquornik | CANADA | NA | Newmarket |
| 283 | Jeff Marks M.D., P.A. | Jeffrey Marks | UNITED STATES | NA | Plantation |
| 284 | Tufts Medical Center | Paul Mathew | UNITED STATES | NA | Boston |
| 285 | The Miriam Hospital Office of Clinical Research | Tony Mega | UNITED STATES | NA | Providence |
| 286 | Oncology Specialists, S. C Advocate Lutheran General Hospital | Chadi Nabhan | UNITED STATES | NA | Park Ridge |
| 287 | Palm Beach Urology Associates, P.A. | Georgis Patsias | UNITED STATES | NA | Wellington |
| 288 | Roswell Park Cancer Institute | Roberto Pili | UNITED STATES | NA | Buffalo |
| 289 | UROLOGY ENTERPRISES | Ronald Roper | UNITED STATES | NA | MARIETTA |
| 290 | Prostate Oncology Specialists | Mark Scholz | UNITED STATES | NA | Marina Del Ray |
| 291 | Carolina Urologic Research Center | Neal Shore | UNITED STATES | NA | Myrtle Beach |
| 292 | Urological Associates of Lancaster | Paul Sieber | UNITED STATES | NA | Lancaster |
| 293 | Virginia Cancer Specialists, PC | Alexander Spira | UNITED STATES | NA | Fairfax |
| 294 | Dr. Steinhoff Clinical Research | Gary Steinhoff | CANADA | NA | Victoria |
| 295 | Medical Oncology Associates of Augusta, P. C. W. G. Watson Medical Center | Donald Townsend | UNITED STATES | NA | Augusta |
| 296 | Comprehensive Cancer Centers of Nevada | Nicholas Vogelzang | UNITED STATES | NA | Las Vegas |
| 297 | Idaho Urologic Institute | Joseph Williams | UNITED STATES | NA | Meridian |
| 298 | Tweed Cancer Care Centre | Ehtesham Abdi | AUSTRALIA | NA | Tweed Heads, NSW |
五、伦理委员会信息
| 序号 | 名称 | 审查结论 | 批准日期/备案日期 |
|---|---|---|---|
| 1 | 复旦大学附属肿瘤医院伦理委员会 | 同意 | 2012-06-11 |
六、试验状态信息
1、试验状态
主动暂停
2、试验人数
| 目标入组人数 | 国内: 16 ； 国际: 1200 ； |
|---|---|
| 已入组人数 | 国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息； |
| 实际入组总人数 | 国内: 15 ； 国际: 1245 ； |
3、受试者招募及试验完成日期
| 第一例受试者签署知情同意书日期 | 国内：2012-08-13； 国际：2011-03-24； |
|---|---|
| 第一例受试者入组日期 | 国内：登记人暂未填写该信息； 国际：登记人暂未填写该信息； |
| 试验完成日期 | 国内：2015-08-07； 国际：2015-08-07； |
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