长春奥拉帕利片III期临床试验-一项针对已完成奥拉帕利先前肿瘤学研究并仍可从持续治疗中取得获益的患者的滚动研究

登记号	CTR20254928	试验状态	进行中
申请人联系人	程艳云	首次公示信息日期	2025-12-11
申请人名称	AstraZeneca AB/ 阿斯利康投资（中国）有限公司

登记号	CTR20254928
相关登记号	暂无
药物名称	奥拉帕利片
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	乳腺癌
试验专业题目	ROSY-O：针对已完成一项先前奥拉帕利肿瘤学研究并且经研究者判断可从继续治疗中获益的患者的滚动研究
试验通俗题目	一项针对已完成奥拉帕利先前肿瘤学研究并仍可从持续治疗中取得获益的患者的滚动研究
试验方案编号	D0817C00098	方案最新版本号	7.0
版本日期:	2023-08-08	方案是否为联合用药	否

申请人名称	[["AstraZeneca AB"],["阿斯利康投资（中国）有限公司"]]
联系人姓名	程艳云	联系人座机	010-56439653	联系人手机号
联系人Email	Yanyun.Cheng@parexel.com	联系人邮政地址	北京市-北京市-朝阳区昆泰国际大厦	联系人邮编	100020

为临床试验结束时可继续获益的患者提供持续的研究治疗，同时监测奥拉帕利片的安全性和耐受性。

试验分类	安全性	试验分期	III期	设计类型	单臂试验
随机化	非随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 99岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["提供已签名并注明日期的书面ICF。"],["根据研究者的判断，患者当前正在从一项AZ 母研究的持续治疗中获益，该研究使用一种AZ 化合物进行且达到了其主要终点或已因其他原因停止。"],["患者参加一项先前的AZ 化合物肿瘤学研究，在该研究中接受奥拉帕利治疗，并持续从治疗中取得临床获益；先前的研究可以是开放性研究或在研究结束时揭盲的盲态研究。"]]
排除标准	[["在母研究终止时有仍然持续、未消退且需要中断治疗的3级或3级以上毒性。"],["目前正在接受任何禁用药物治疗。"],["目前正在参加经判定为在科学或医学上与本研究不相容的其他任何类型的医学研究。"],["因毒性或疾病进展永久终止母研究"],["在当地/国家法规允许的情况下，患者可在当地免费获得已上市药物"]]

试验药

[["中文通用名:奥拉帕利片 英文通用名:OlaparibTablets 商品名称:利普卓","剂型:片剂 规格:100mg 用法用量:300mg（两片150mg规格片剂，每日两次，连续服用）.当需要降低剂量时，患者将服用一片150mg片剂和一片100mg片剂，每日两次，或两片100mg片剂，每日两次，或一片150mg片剂，每日两次，或一片100mg片剂，每日两次。 用药时程:符合终止治疗的标准或者患者退出。"],["中文通用名:奥拉帕利片 英文通用名:OlaparibTablets 商品名称:利普卓","剂型:片剂 规格:150mg 用法用量:300mg（两片150mg规格片剂，每日两次，连续服用）.当需要降低剂量时，患者将服用一片150mg片剂和一片100mg片剂，每日两次，或两片100mg片剂，每日两次，或一片150mg片剂，每日两次，或一片100mg片剂，每日两次。 用药时程:符合终止治疗的标准或者患者退出。"]] 序号 名称 用法

对照药

暂未填写此信息 序号 名称 用法

主要终点指标及评价时间	[["报告的严重不良事件和特别关注的不良事件","截至最后一次给药后30天。","安全性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	暂未填写此信息 序号 指标 评价时间 终点指标选择

1	姓名	李薇	学位	医学博士	职称	主任医师
	电话	13756661267	Email	jdyylw@163.com	邮政地址	吉林省-长春市-新民大街1号
	邮编	130031	单位名称	吉林大学第一医院

[["吉林大学第一医院","李薇","中国","吉林省","长春市"],["CHU UCL Namur - Site Ste Elisabeth","Stephanie Henry","比利时","Namur","Namur"],["UZ Leuven - Radiotherapie-Oncologie","Els Van Nieuwenhuysen","比利时","Vlaams Brabant","Leuven"],["Instituto COI de pesquisa, educacao e gestao","Paulo Mora","巴西","Rio de Janeiro","Rio de Janeiro"],["Medical Center Nadezhda Clinical","Georgi Zhbantov","保加利亚","Sofia","Sofia"],["Complex Oncology Center - Oncology Department","Antoaneta Tomova","保加利亚","Sofia","Sofia"],["MHAT Central Hospital, OOD - Oncology Department","Rumyana Ilieva","保加利亚","Plovdiv","Plovdiv"],["CHUM - Centre de recherche de l’Universite de Montreal","Diane Provencher","加拿大","Quebec","Montreal"],["University of Toronto - Sunnybrook Health Sciences Centre - Medical Oncology & Hematology","Helen MacKay","加拿大","Quebec","Toronto"],["Maisonneuve-Rosemont Hospital","Suzanne Fortin","加拿大","Quebec","Montreal"],["Jewish General Hospital","Susie Lau","加拿大","Quebec","Montreal"],["CHU de Quebec-HSS - Breast Cancer","Julie Lemieux","加拿大","Quebec","Quebec"],["McGill University Health Center - Royal Victoria Hospital - Oncology","Lucy Gilbert","加拿大","Quebec","Montreal"],["Dalhousie University - Queen Elizabeth II (QEII) Health Sciences Centre - Nova Scotia Cancer Centre (NSCC)","Katharina Kieser","加拿大","Nova Scotia","Halifax"],["Kingston General Hospital","Josee-Lyne Ethier","加拿大","Ontario","Kingston"],["Trillium Health Partners - The Credit Valley Hospital","Tomer Feigenberg","加拿大","Ontario","Mississauga"],["Princess Margaret Cancer Centre - Drug Development Program","Amit Oza","加拿大","Ontario","Toronto"],["The Ottawa Hospital - Oncology","Johanne Weberpals","加拿大","Ontario","Ottawa"],["Vseobecna fakultni nemocnice v Praze - Gynekolog-porodnicka klinika","David Cibula","捷克","Praha, Hlavni Mesto","Praha 2"],["Fakultni nemocnice Ostrava - Onkologicka klinika","Jan Kummel","捷克","Ostrava-mesto- Ostrava","Poruba"],["Fakultni nemocnice v Motole - Onkologicka klinika","Zdenek Linke","捷克","Praha, Hlavni Mesto","Praha 5"],["Fakultni nemocnice Olomouc - Onkologicka klinika","Bohuslav Melichar","捷克","Olomouc","Olomouc"],["Masarykuv onkologicky ustav - Odd. gynekologicke onkologie","Maria Zvarikova","捷克","Jihomoravsky Kraj","Brno"],["Fakultni nemocnice Brno - Gynekologicko-porodnicka klinika","Vit Weinberger","捷克","Jihomoravsky Kraj","Brno"],["Aalborg University Hospital, Clinical Research Unit - Department of Oncology","Charlotte Haslund","丹麦","North Jutland","Aalborg"],["Kuopio University Hospital","Henna Karkkainen","芬兰","Ita-Suomen","laani- Kuopio"],["Hopital Prive des Cotes d'Armor- Service oncologie","Jerome Martin-Babau","法国","Finistere","PLERIN"],["Centre Leon Berard - Oncologie medicale","Isabelle-Laure Ray-Coquard","法国","Rhone","Lyon"],["APHP - Hopital Paul Brousse - Oncologie medicale et digestive","Pascal Hammel","法国","Val-de-Marne","Villejuif"],["Centre de Lutte Contre le Cancer - Centre Oscar Lambret","Aurelien Carnot","法国","Pas-de-Calais","Lille"],["Universitatsklinikum Carl Gustav Carus - Frauenheilkunde, Geburtshilfe","Pauline Wimberger","德国","Sachsen","Dresden"],["Orszagos Onkologiai Intezet","Imre Pete","匈牙利","Pest","Budapest"],["Szent Margit Korhaz","Katalin Boer","匈牙利","Pest","Budapest"],["The Christie NHS Foundation Trust - Christie Hospital","Andrew Clamp","英国","Manchester","Manchester"],["The University of Edinburgh - Western General Hospital","Caroline Michie","英国","Edinburgh","Edinburgh"],["The Royal Marsden NHS Foundation Trust","Zoe Kemp","英国","London","London"],["University Hospitals Birmingham NHS Foundation Trust","Sarah Williams","英国","England","Edgbaston"],["NHS Greater Glasgow and Clyde - The Beatson West of Scotland Cancer Centre - Haematology","Rosalind Glasspool","英国","Glasgow","Glasgow"],["Taunton and Somerset NHS Foundation Trust","Emma Cattell","英国","Somerset","Taunton"],["Hull University Teaching Hospitals NHS Trust - Department of Respiratory Medicine","Georgios Bozas","英国","Cottingham","Cottingham"],["The Chaim Sheba Medical Center Tel Hashomer - Internal Medicin D & Hypertens","Ronnie Shapira Frommer","以色列","Yerushalayim","Tel Hashomer"],["Tel Aviv Sourasky Medical Center - Internal Medicin","Tamar Safra","以色列","Tel-Aviv","Tel-Aviv"],["Rambam Health Care Campus - Pulmonology","Emad Matanes","以色列","Tel-Aviv","Haifa"],["Rabin Medical Center - Beilinson Hospital - Haematology","Salomon. M Stemmer","以色列","Tel-Aviv","Petah Tikva"],["Shaare Zedek Medical Center","Ora Rosengarten Solange","以色列","Yerushalayim","Jerusalem"],["Hadassa Ein Karem Medical Center - Urology","Ayala Hubert","以色列","Yerushalayim","Jerusalem"],["Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS","Sandro Pignata","意大利","Napoli","Napoli"],["Istituto Oncologico Veneto (IOV)","Valentina Guarneri","意大利","Padova","Padova"],["Istituto di Candiolo IRCCS","Vanesa Gregorc","意大利","Torino","Candiolo"],["Centro Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Vanda Salutari","意大利","Roma","Roma"],["ASST Spedali Civili di Brescia","Germana Tognon","意大利","Lombardia","Brescia"],["Ospedale San Raffaele, IRCCS - Ginecologia","Giorgia Mangili","意大利","Milano","Milano"],["Ospedale Vito Fazzi, ASL Lecce","Graziana Ronzino","意大利","Puglia","Lecce"],["AOU Ospedali Riuniti Umberto I – G.M. Lancisi – G. Salesi","Rossana Berardi","意大利","Ancona","Ancona"],["Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I di Torino","Annamaria Ferrero","意大利","Torino","Torino"],["Borgo Roma, Policlinico G. Rossi, AOU Integrata Verona - Oncologia","Michele Milella","意大利","Verona","Verona"],["PO A. Manzoni di Lecco, ASST Lecco - Nefrologia","Antonio Ardizzoia","意大利","Lecco","Lecco"],["Policlinico S. Orsola Malpighi, AOU di Bologna","Claudio Zamagni","意大利","Bologna","Bologna"],["Ospedale Cannizzaro, AO per l'Emergenza Cannizzaro","Paolo Scollo","意大利","Catania","Catania"],["IEO - Istituto Europeo di Oncologia, IRCCS","Nicoletta Colombo","意大利","Milano","Milano"],["Uniwersytecki Szpital Kliniczny w Poznaniu - Oddz.Ginekologii Onkologicznej","Radoslaw Madry","波兰","Wielkopolskie","Poznan"],["Bialostockie Centrum Onkologii im. M. Sklodowskiej–Curie - Oddzial Onkologii Ginekolog.","Beata Mackowiak - Matejczyk","波兰","Podlaskie","Bialystok"],["NZOZ Innowacyjna Medycyna","Tomasz Huzarski","波兰","Zachodniopomorskie","Grzepnica"],["Wojewodzki Szpital Specjalistyczny w Olsztynie - Oddzial Ginekologii Onkologicznej","Magdalena Sikorska","波兰","Warminsko-Mazurskie","Olszyn"],["Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli - I Oddzial Ginekologii Onkologicznej COZL","Dariusz Kieszko","波兰","Lubelskie","Lublin"],["Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie - Oddzial Radioterapii","Krystyna Bratos","波兰","Wielkopolskie","Poznan"],["Instituto Portugues de Oncologia Do Porto FG, EPE","Marta Ferreira","葡萄牙","Regiao Autonoma da Madeira","Porto"],["H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia","Luis Marques da Costa","葡萄牙","Lisboa","Lisboa"],["Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of Internal Medicine","Joohyuk Sohn","韩国","NA","Seoul"],["Samsung Medical Center - Hematology & Oncology","Yeon Hee Park","韩国","NA","Seoul"],["Seoul National University Hospital","Jae-Weon Kim","韩国","NA","Seoul"],["Samsung Medical Center","Chel Hun Choi","韩国","NA","Seoul"],["Korea Institute of Radiological & Medical Sciences","Sang-Young Ryu","韩国","NA","Seoul"],["Seoul National University Hospital","Do-Youn Oh","韩国","NA","Seoul"],["Samsung Medical Center - Family Medicine","Joon Oh Park","韩国","NA","Seoul"],["Gangnam Severance Hospital, Yonsei University Health System","Jae-Hoon Kim","韩国","NA","Seoul"],["St. Petersburg Clinical Research and Practical Center of Specialized Types of Medical Care (Oncologic) - Oncology","Fedor Moiseenko","俄罗斯","Saint-Petersburg","Saint-Petersburg"],["Institute for Oncology","Erik Skof","斯洛文尼亚","Ljubljana","Ljubljana"],["Hospital Universitari i Politecnic La Fe","Ana Santaballa Bertran","西班牙","Valencia","Valencia"],["Hospital Universitario Miguel Servet - Oncologia Medica","Ana Herrero Ibanez","西班牙","Zaragoza","Zaragoza"],["Institut Catala D'oncologia","Beatriz Pardo Burdalo","西班牙","Barcelona","L'Hospitalet De Llobregat"],["Institut Catala d'Oncologia-Hospital Universitari Germans Trias i Pujol - Oncologia Medica","Iris Teruel Garcia","西班牙","Barcelona","Barcelona"],["Clinica Universidad de Navarra - Oncología Médica","Marta Santisteban","西班牙","Navarra","Pamplona"],["Hospital Universitario Virgen de las Nieves","Encarnacion Gonzalez Flores","西班牙","Madrid","Granada"],["Clinica Universidad de Navarra - Oncologia","Marta Santisteban","西班牙","Madrid","Madrid"],["Hospital Universitario Reina Sofia","Maria Jesus Rubio","西班牙","Cordoba","Cordoba"],["Hospital Universitario Donostia","Isabel Alvarez Lopez","西班牙","Guipuzcoa","Donostia"],["Hospital Universitario Vall d'Hebron - Oncologia Medica","Judith Balmana Gelpi","西班牙","Barcelona","Barcelona"],["Hospital Universitario 12 de Octubre - Oncologia Medica","Luis Manuel Manso Sanchez","西班牙","Madrid","Madrid"],["Hospital Alvaro Cunqueiro - Oncologia Medica - Servicio de Oncologia","Isabel Lorenzo Lorenzo","西班牙","Pontevedra","Vigo"],["Hospital Universitario La Paz","Andres Redondo Sanchez","西班牙","Madrid","Madrid"],["Hospital de la Santa Creu i Sant Pau","Cristina Martin Lorente","西班牙","Barcelona","Barcelona"],["Skanes University Hospital Lund ( Site 1200)","Maria Bjurberg","瑞典","Skane lan [SE-12]","Skane lan [SE-12]"],["Taipei Veterans General Hospital","Ling-Ming 令民 Tseng 曾","中国台湾","台湾","台北"],["Hacettepe University Medical Faculty - Medical Oncology","Sercan Aksoy","土耳其","Ankara","Ankara"],["Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi - Medical Oncology","Havva Cinkir","土耳其","Gaziantep","Sahinbey"],["Istanbul University Oncology Institute","Naziye Ak","土耳其","Istanbul","Istanbul"],["Memorial Sloan Kettering - I Chemotherapy Practice/Investigational Drug Service","Ying Liu","美国","New York","Rockville Centre"],["Columbia University Irving Medical Center","Jason Wright","美国","New York","New York"],["University of Pennsylvania - Abramson Cancer Center","Fiona Simpkins","美国","Pennsylvania","Pennsylvania"],["JTCC at Hackensack UMC","Donna McNamara","美国","New Jersey","Hackensack"],["Karmanos Cancer Center","Robert Morris","美国","Michigan","Detroit"],["Women & Infants Hospital of Rhode Island","Cara Mathews","美国","Rhode Island","Providence"],["Virginia Piper Cancer Institute","Christian Squillante","美国","Minnesota","Minneapolis"],["West Cancer Center","Mark Reed","美国","Tennessee","Germantown"],["Abington Memorial Hospital (AMH) - Rosenfeld Cancer Center","Elizabeth Burton","美国","Pennsylvania","Abington"],["University of Texas Physicians at Memorial Hermann Medical P","Joseph Lucci","美国","Texas","Houston"],["Montefiore Medical Center - Oncology Investigational","Nicole Nevadunsky","美国","New York","Bronx"],["West Penn Hospital","Ali Amjad","美国","Pennsylvania","Pittsburgh"],["Willis-Knighton Physician Network","Destin Black","美国","Louisiana","Shreveport"],["Greater Baltimore Medical Center (GBMC)","Paul Celano","美国","Maryland","Baltimore"],["Lynn Clinical Research Center","Stephen Grabelsky","美国","Florida","Boca Raton"],["Cedar Sinai Medical Cancer - Oncology","Jin Bitar","美国","California","West Hollywood"],["Dana Farber Cancer Institute - Hospital","Beverly Moy","美国","Massachusetts","Boston"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["吉林大学第一医院伦理委员会","同意","2025-10-15"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 1 ； 国际: 186 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 185 ；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：2020-08-04；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2020-08-04；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；