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出境医 / 临床实验 / 他奎莫德治疗转移性，去势难治性前列腺癌的研究
他奎莫德治疗转移性，去势难治性前列腺癌的研究
基本信息
| 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 | ||
公示的试验信息
一、题目和背景信息
| 登记号 | CTR20130169 | ||
|---|---|---|---|
| 相关登记号 | |||
| 药物名称 | 他奎莫德胶囊 曾用名: | ||
| 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 | |
| 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 |
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2
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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 | |
| 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) | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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6、数据安全监查委员会（DMC）
有
7、为受试者购买试验伤害保险
有
四、研究者信息
1、主要研究者信息
| 1 | 姓名 | Micheal Carducci, M.D. | 学位 | 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 | 姓名 | 叶定伟，医学博士 | 学位 | 职称 | 科室主任 | |
|---|---|---|---|---|---|---|
| 电话 | +86 10 13701663571 | dwyeli@yahoo.com.cn | 邮政地址 | 上海市东安路270号 | ||
| 邮编 | 200030 | 单位名称 | 复旦大学附属肿瘤医院 | |||
2、各参加机构信息
| 序号 | 机构名称 | 主要研究者 | 国家 | 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 | Ramb |
