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  • D0316在EGFR突变局部晚期或转移性非小细胞肺癌患者中的 II 期临床试验
    产品情况

    BPI-D0316是针对T790M突变的第三代表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)。目前针对EGFR突变非小细胞肺癌的治疗,以第一代EGFR-TKI为主,但是患者在接受第一代EGFR-TKI治疗一定时间后往往会产生耐药突变,其中T790M突变占60%以上。研究表明,针对T790M突变的第三代EGFR-TKI能够显著改善患者的生存质量,提高患者的总生存期。

    试验信息

    方案号

    IBIO-102

    方案名称

    赢红包的游戏大厅,赢红包的游戏大厅APP下载D-0316ZAIEGFRTUBIANJUBUWANQIHUOZHUANYIXINGFEIXIAOXIBAOFEIAIHUANZHEZHONGDEIIQILINCHUANGSHIYAN

    版本号/日期

    DI3.0BAN/2019NIAN10YUE14RI

    申办者

    YIFANGSHENGWUKEJI(SHANGHAI)YOUXIANGONGSI

    试验分期

    IIQI

    适应症

    JIWANGSHIYONGEGFR-TKINAIYAOHOUCHANSHENGT790MTUBIANDEJUBUWANQIHUOZHUANYIXINGFEIXIAOXIBAOFEIAI

    试验目的   

    主要目的

    GUANCHAKOUFUD-0316ZAIJIWANGLINCHUANGSHIYONGYIDAIHUOERDAIEGFR-TKINAIYAOHOUCHANSHENGT790MTUBIANDEJUBUWANQIHUOZHUANYIXINGFEIXIAOXIBAOFEIAIHUANZHEZHONGDELIAOXIAO。

    次要目的

    PINGGUKOUFUD-0316ZAIJIWANGLINCHUANGSHIYONGYIDAIHUOERDAIEGFR-TKINAIYAOHOUCHANSHENGT790MTUBIANDEJUBUWANQIHUOZHUANYIXINGFEIXIAOXIBAOFEIAIHUANZHEZHONGDEANQUANXING。                       

    探索颅内客观缓解率(iORR)和颅内无进展生存期(iPFS)。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载PINGJIAKOUFUD-0316HOUYAOWUDEQUNTIYAODONGXUETEZHENG(PopPK),BINGTANSUOYAOWUBAOLUYULIAOXIAO、ANQUANXINGDEGUANXI。

    试验设计

    BENYANJIUWEIDUOZHONGXIN、KAIFANG、DANBEIIIQILINCHUANGYANJIU,PINGGUYANJIUYAOWUZAIJIWANGJIESHOUYIDAIHUOERDAIEGFR-TKIZHILIAOHOUCHANSHENGNAIYAOQIEEGFR-T790MTUBIANYANGXINGDEJUBUWANQIHUOZHUANYIXINGNSCLCHUANZHEZHONGDELIAOXIAOHEANQUANXING。

    JIHUAXUANZEYUE50GEYANJIUZHONGXINJINXINGLINCHUANGSHIYAN。QIANSHUZHIQINGTONGYISHUDEHUANZHEJINGGUORUXUAN/PAICHUBIAOZHUNDESHAIXUANHOU,HEGEDEHUANZHEJIANGXIANJIESHOUYIGEZHOUQIDE75mg QD D-0316ZHILIAO。RUODIYIZHOUQINEIWEIFASHENGCTCAE 4.03≥2JIDEXUEXIAOBANJIANGDIHUOTOUTONG,ZESHENGGAOJILIANGZHI100mgYONGYAOZHIZHIJIBINGJINZHAN(RECIST 1.1)、MANZUTUICHUBIAOZHUNHUOYANJIUZHONGZHIBIAOZHUN;RUODIYIZHOUQINEISHOUSHIZHEFASHENGXUEXIAOBANJIANGDIHUOTOUTONGDADAOCTCAE 4.03≥2JI,ZEWEICHI75mg QDYONGYAOZHIZHIJIBINGJINZHAN(RECIST 1.1)、MANZUTUICHUBIAOZHUNHUOYANJIUZHONGZHIBIAOZHUN。MEIRIYICI,MEIGEZHOUQIWEI21TIAN。GENJURECIST v1.1BIAOZHUN,JIXIANSHIJINXINGZHONGLIUPINGGU,SHOUCIYONGYAOHOUMEI6ZHOUJINXINGYICIZHONGLIUPINGGU。

    DANG2.1BANFANGANZHENGSHISHISHISHI,JIANGZHONGZHIFANGAN(BANBEN:1.1,RIQI:2019NIAN1YUE2RI)GUIDINGDE50mg QDJILIANGZUDERUZU。YIRUZUDESHOUSHIZHE,JIANGJIXUFUYONG50mg QDZHIJIBINGJINZHAN(RECIST 1.1)。

    BENYANJIUZHUYAOZHONGDIANSHIDULILIAOXIAOPINGGUWEIYUANHUIPINGGUDEKEGUANHUANJIELV(ORR),GUANJIANCIYAOZHONGDIANSHIDULILIAOXIAOPINGGUWEIYUANHUIPINGGUDEKEGUANHUANJIECHIXUSHIJIAN(DOR)、WUJINZHANSHENGCUNQI(PFS)、LUNEIKEGUANHUANJIELV(iORR)HELUNEIWUJINZHANSHENGCUNQI(iPFS),YIJIZONGSHENGCUNQI(OS)、HRQoLXIANGDUIYUJIXIANDEBIANHUA(FACT-LDI4BANHEFACT-LCSDI4BAN)HEANQUANXING。

    BENYANJIUJIANGZAIZHISHAO100LISHOUSHIZHEZHONGJINXINGXISHUCAIXUE,GAICAIXUEJIYUSHOUSHIZHEZIYUANDEYUANZE,BINGZAIQIANSHUPopPKZHIQINGTONGYISHUHOUJINXING,XUEYANGYONGYUJIANCED-0316JIQIDAIXIEWUDENONGDU,JINXINGPopPKFENXI。

    BINGLIZONGSHU。

    75→100mg剂量组(2.1版方案):286例受试者

    50mg剂量组(1.1版方案):最多208例受试者

    研究单位

    约50个中心

    入选标准

    赢红包的游戏大厅,赢红包的游戏大厅APP下载1. ZIYUANQIANSHUSHUMIANZHIQINGTONGYISHU,NENGGOULIJIEHEZUNSHOUSHIYANFANGANYAOQIU。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载2. NIANLING≥18ZHOUSUI。

    3. ZUZHIHUOXIBAOBINGLIXUEQUEZHENDEJUBUWANQI(AJCCDI8BANIIIBQIHEIIICQI)HUOZHUANYIXINGFEIXIAOXIBAOFEIAI(AJCCDI8BANIVQI),QIEBUSHIHEGENZHIXINGSHOUSHUHUOFANGLIAO。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载4. ZAIJIWANGSHIYONGYIDAIHUOERDAIEGFR-TKI(LIRU:JIFEITINI、ELUOTINIDENG)ZHILIAOQIJIANHUOZHILIAOHOU,YINGXIANGXUEQUERENCHUXIANJIBINGJINZHAN。

    5. HUOQUMOCIEGFR-TKIZHILIAOJIBINGJINZHANHOUDEZUZHI,JINGZHONGXINSHIYANSHIJIANCEEGFR T790MTUBIANDEHUANZHE。

    6. ECOGPINGFEN0~1FEN。

    7. YUJISHENGCUNQIBUSHAOYU12ZHOU。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载8. GENJURECIST 1.1,JINGYINGXIANGXUEZHENDUANSHAIXUANQICUNZAIZHISHAOYIGEWEIJIESHOUFANGLIAOZHILIAODEKECELIANGBINGZAO。

    9. ZIYUANTONGYIZHENGGEYANJIUQIJIANJIMOCIJIYAOHOU6ZHOUNEICAIYONGCHANGGUIZUGOUYOUXIAODEBIYUNCUOSHI【DUIYUNVXING:1.KOUFU、ZHUSHEBIYUNYAOHUOZHIRUJISUBIYUNFA;2.GONGNEIJIEYUQIHUOGONGNEIJIEYUXITONG;3.PINGZHANGBIYUNFA:YOUSHAJINGZUOYONGDEBIYUNTAOHUOZUSAIMAO(GEMOHUOGONGJING/QIONGLONGMAO)。DUIYUNANXING:1.YOUSHAJINGZUOYONGDEBIYUNTAO;2.SHOUSHUJUEYU(RU:SHUANGCEGAOWANQIECHU、SHUANGCESHUJINGGUANQIECHU)】;JUEJINGQIANYOUSHENGYUKENENGDE(MANZUXIASHUTIAOJIANRENWEIYOUJUEJINGQIANSHENGYUKENENG:1.WEIXINGSHUANGCESHULUANGUANJIEZHA、ZIGONGQIECHU、SHUANGCELUANCHAOQIECHU;2.MOCIYUEJINGZHISHAIXUANSHI<2NIAN)NVXINGHUANZHEXUPAICHURENSHEN(JIRENSHENSHIYANYINXING);QIECHUYUFEIBURUQI。

    排除标准

    1. HEBINGQITAEXINGZHONGLIU(LINCHUANGZHIYUDEGONGJINGYUANWEIAI、JIDIXIBAOHUOLINZHUANGSHANGPIXIBAOPIFUAI、JIAZHUANGXIANRUTOUZHUANGAICHUWAI)。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载2. YANJIUYAOWUZHILIAOQIAN10TIANNEISHIYONGLEDIYIDAIHUOZHEDIERDAIEGFR-TKIZHILIAO(LIRU:JIFEITINI、ELUOTINI);CENGSHIYONGDI3DAIEGFR-TKI(RUAZD9291、AIWEITINIHEAIFUTINIDENG)。

    3. ZAISHOUCIJIYAOZHIQIAN4ZHOUNEIJINXINGLEHUALIAOHUOMIANYIZHILIAO;ZAISHOUCIJIYAOQIAN2ZHOUNEIJIESHOULEFANGSHEZHILIAO。JIWANGJIESHOUGUOERXIANJIYISHANGXITONGXINGHUALIAOHUOMIANYIZHILIAO。

    4. YANJIUYAOWUZHILIAOQIAN28TIANNEIJIESHOUGUOWAIKESHOUSHUZHE,DANYANJIUZHEPANDUANBUYINGXIANGCANJIASHIYANDEXIAOSHOUSHU(LIRU:BAYADENG)CHUWAI;HUOZAIYANJIUQIJIANJIHUAJINXINGDASHOUSHUDEHUANZHE。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载5. SHAIXUANQIAN2ZHOUNEICHUXIANZHENGZHUANGHUOTIZHENGMINGXIANEHUA(RUSHAIXUANQIAN2ZHOUNEICHUXIANDALIANGXIONGSHUI,KONGZHIXIONGSHUIHOUKEKAOLVSHAIXUAN),YANJIUZHEPANDUANBUSHIHECANJIASHIYAN。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载6. JIWANGZHILIAOHOUDEDUXINGFANYINGWEIHUIFU,SHIYANYAOWUJIYAOQIANGENJUCTCAE v4.03PANDUANWEI2JIHUO2JIYISHANG,QIZHONGTUOFACHUWAI。

    7. CUNZAIJISUIYAPO,YOUZHENGZHUANGHUORUZUQIAN4ZHOUXUYAOLEIGUCHUNZHILIAODEBUWENDINGNAOZHUANYI。NAOZHUANYIWUZHENGZHUANGHUOJINGZHILIAOHOUWENDING4ZHOUYISHANGQIEBUXUYAOLEIGUCHUNZHILIAODEHUANZHEKEYIRUZU。NAOMOZHUANYILIUHUANZHEBUYURUZU。

    8. 任何临床证据表明患有重度或未控制的疾病,研究者认为不适合参加本临床试验或会影响患者对研究方案依从性的情况,例如经药物治疗后仍不能控制的高血压患者(SBP>160mmHg或DBP>100mmHg)、活动性易出血体质患者、活动性感染患者(如乙型肝炎、丙型肝炎、HIV-1/2抗体阳性、梅毒螺旋体抗体阳性(滴度检测结果为阴性者除外))。活动性乙型肝炎定义乙肝核心抗体(HBcAb)或乙肝表面抗原(HBsAg)阳性,且HBV DNA ≥ 2000 IU/ml(相当于104赢红包的游戏大厅,赢红包的游戏大厅APP下载拷贝/ml)。活动性丙型肝炎定义为HCV RNA高于检测下限。

    9. ZAIJINGXIZHUANGTAIXIA,SHAIXUANQIXINDIANTUXIAOZHENGDEQTJIANQI(QTcF)JIEGUOYICHANGZHE,MEICIZHISHAOJIANGE4XIAOSHI,FUCE2CI,3CIXINDIANTUJIANCHADEPINGJUNQTcF:NANXING≥450 msec ,NVXING≥470 msec。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载10. GEZHONGYOULINCHUANGYIYIDEXINLV、CHUANDAO、JINGXIECGXINGTAIYICHANG,LIRUWANQUANXINGZUOSHUZHICHUANDAOZUZHI、IIIDUCHUANDAOZUZHI、IIDUCHUANDAOZUZHI、PRJIANQI>250msec。

    11. CUNZAIZENGJIAQTcYANZHANGFENGXIANHUOXINLVSHICHANGSHIJIANFENGXIANDEGEZHONGYINSU,LIRUXINLISHUAIJIE、DIJIAXUEZHENG、XIANTIANXINGZHANGQTZONGHEZHENG、JIAZUSHIZHONGYIJIQINSHUYOUZHANGQTZONGHEZHENGHUOBUDAO40SUIJIUBUMINGYUANYINCUSI;SHIYANYAOWUSHOUCIJIYAOQIAN1ZHOUZHENGZAISHIYONGHUOYANJIUQIJIANXUYAOHEBINGSHIYONGYIZHIHUOKENENGYOUDAOQTJIANQIYANZHANGHE/HUOJIANDUANNIUZHUANXINGSHIXINGXINDONGGUOSUFENGXIANDEYAOWU;CHAOSHENGXINDONGTUJIANCHA:ZUOXINSHISHEXUEFENSHU(LVEF)≤50%HUOQITAYANJIUZHEPANDUANYOULINCHUANGYIYIDEYICHANG。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载12. YANZHONGHUXIXITONGJIBING,RUJIANZHIXINGFEIJIBING、ZHONGDUXIAOCHUAN、FEISHUANSAIDENG。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载13. RENHEYINGXIANGHUANZHETUNFUYAOWUHUOKOUFUXISHOUZHANGAIDEQINGKUANG,LIRU:YANZHONGMANXINGWEICHANGDAOJIBING、JIESHOUGUOWEICHANGDAOSHOUSHU、NANZHIXINGEXINHUOOUTUZHENGZHUANGDENG。

    14. CHUXIANYIXIARENHEYIXIANGSHIYANSHIZHIBIAOYICHANG:

    ● 绝对中性粒细胞计数(ANC)<1.5×109/L;

    ● 血小板计数(PLT)<100×109/L;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载● XUEHONGDANBAI(Hb)<90g/L;

    ● BINGANSUANANJIZHUANANMEI(ALT)HUOTIANMENDONGANSUANANJIZHUANANMEI(AST)>2.5BEIZHENGCHANGZHISHANGXIAN(ULN),HUOGANZHUANYISHIALTHUOAST>5BEIULN;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载● ZONGDANHONGSU>1.5BEIULN,HUOGANZHUANYISHI>3BEIULN;

    ● XUEQINGJIGAN(SCr)>1.5BEIULNHUOJIGANQINGCHULV<50ml/min(GENJUCockcroft-GaultGONGSHIJISUAN)。

    15. DUIYANJIUYAOWUJIQIZHIJIDERENHECHENGFENYOUGUOMINSHIHUOYISIGUOMINZHENGZHUANG。

    16. SHIYANYAOWUSHOUCIJIYAOQIAN1ZHOUNEIZHENGZAISHIYONGHUOYANJIUQIJIANXUYAOSHIYONGCYP3A4、CYP3A5、CYP 2D6HECYP 2C8QIANGYIZHIJIHUOYOUDAOJI。

    17. ZUIJINYICICANJIAQITAYAOWUHUOYILIAOQIXIEDELINCHUANGSHIYAN,SHOUCIJIYAOQIANMOCIZHILIAOSHAOYU4ZHOU,HUOJIHUAZAIBENYANJIUQIJIANCANYURENHEQITALINCHUANGSHIYAN。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载18. YOUYANJIUZHEPANDUANDEBUSHIHEJINRUBENYANJIUDEQITAQINGKUANG。

    研究者信息

    研究者信息---11.9更新.jpg

  • CM082间歇性给药治疗湿性年龄相关性黄斑变性(wAMD)的  II 期临床试验
    产品情况

    伏罗尼布(CM082)是我国自主研发拥有全球自主知识产权的口服的小分子、多靶点(抑制VEGFR/PDGFR)新药,对新生血管有很强的抑制作用,且相对于同类药物有较好的安全性。

    试验信息

    赢红包的游戏大厅,赢红包的游戏大厅APP下载GAIYAOWUDELINCHUANGYANJIUYIHUOGUOJIASHIPINYAOPINJIANDUGUANLIZONGJUPIZHUN(PIJIANHAO:2014L02603)。JINGGUOWUHANDAXUERENMINYIYUANLUNLIWEIYUANHUIPIZHUN,BAOZHENGLINCHUANGYANJIUDEKEXUEXING,FUHEYIXUELUNLIXING。ZHEIXIANGYANJIUNIMIANXIANGQUANGUOZHAOMU28-40MINGHUANZHENARULINCHUANGSHIYAN,WUHANDAXUERENMINYIYUANYANKEZHONGXINSHENYINJIAOSHOUWEIZHUYAOYANJIUZHE。

    参加本项研究的主要条件:

    (1) NIANLING≥50ZHOUSUIDESHOUSHIZHE;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(2)JINGYANKEJIANCHAQUEZHENwAMD,TONGSHIYINGGUANGSUXUEGUANZHAOYING(FA)HEGUANGXUEXIANGGANDUANCENGSAOMIAOCHENGXIANGSHU(OCT)ZHENGMINGYOUJIFAYUAMDDEHUODONGXINGMAILUOMOXINSHENGXUEGUANXINGCHENG(CNV),SHIYANYANBIXUTONGSHIJUYOUYIXIABINGBIANTEZHENG:

    • HUANGBANXIAHUOJINHUANGBANQUSUNSHANGZONGMIANJI<12 SHIPANMIANJI;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载• CNVYOUMINGQUEDESHENCHUHUOHUODONGXINGCHUXUE。

    (2)JIWANGWEIJIESHOUGUOKANGVEGFLEIYAOWU(RU:LEIZHUDANKANG, BEIFADANKANG HUO ABOXIPUDENG)ZHILIAO,HUOSHAIXUANQIANRENHEYIZHIYANHUOQUANSHENJIESHOUGUOKANGVEGFLEIYAOWUZHILIAODETINGYAOSHIJIANZHISHAOWEI5GEYAOWUBANSHUAIQI;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(2)NENGLIJIEBINGZIYUANQIANSHUZHIQINGTONGYISHU,ZUNCONGYANJIUFANGAN,NENGJIESHOUSUOYOUYANJIUGUANCHAJIJIANCHA。

    研究者信息

    研究者信息.jpg

  • BPI-16350在晚期实体瘤患者中的安全性和耐受性I 期临床试验
    产品情况

    BPI-16350是贝达自主研发的抗肿瘤新药,是具有全新结构的细胞周期蛋白依赖性激酶 CDK4 和CDK6抑制剂。BPI-16350针对的靶点为CDK4/6,CDK4/6是调节细胞周期的关键因子,能够触发细胞周期从生长期(G1期)向DNA复制期(S期)转变。BPI-16350能特异性地和CDK4/6结合而抑制其激酶活性,抑制癌细胞增殖、转移等相关的信号传导,将细胞周期阻滞于G1期,从而起到抑制肿瘤细胞增殖的作用。

    试验信息

    SHIYANMUDE:PINGGUBPI-16350ZAIWANQISHITILIUHUANZHEZHONGDEANQUANXINGHENAISHOUXING,CHUBUPINGGUBPI-16350ZAIWANQISHITILIUHUANZHEZHONGDELIAOXIAO。

    赢红包的游戏大厅,赢红包的游戏大厅APP下载SHIYANFENLEI:ANQUANXINGHEYOUNAISHOUXING                                             SHIYANFENQI:I QI

    赢红包的游戏大厅,赢红包的游戏大厅APP下载SHEJILEIXING:(1) JILIANGDIZENGYANJIU:CAIYONG“3+3”DESHIYANSHEJI       (2)  KUODARUZUYANJIU

    赢红包的游戏大厅,赢红包的游戏大厅APP下载SUIJIHUA:FEISUIJIHUA                          MANGFA:KAIFANG                   SHIYANFANWEI:GUONEISHIYAN

    入组人数: 

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(1) JILIANGDIZENGYANJIU:YUERU18-54LIHUANZHE。

    (2) KUODARUZUYANJIU:MEIGEJILIANGZUYUERUZU12LIHUANZHE。

    入选标准:

    (1) ZUZHIXUEHUOXIBAOXUEQUEZHENWEIWANQISHITILIUHUANZHE,XIANYOUDEBIAOZHUNZHILIAOFANGANWUFAHUOYI,QIEBUSHIHEJINXINGYIZHIYUWEIMUDEDESHOUSHUQIECHUHUOFANGSHEZHILIAO;

    (2) YOURECIST V.1.1 DINGYIDEKECELIANGBINGZAO,JIWANGJIESHOUGUOFANGLIAOHUOQITAJUBUZHILIAODEZHONGLIUBINGZAO,JINZAIWANCHENGZHILIAOHOUMINGQUEJILUYOUZAIZHILIAOBUWEICHUXIANJIBINGJINZHANDEQINGKUANGXIASHIWEIKECELIANGBINGZAO;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(3) NIANLING≥18QIE≤70SUI;

    (4) YUQISHENGCUN≥12ZHOU;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(5) MEIGUODONGBUZHONGLIUXIEZUOZU(ECOG)TINENGZHUANGTAIPINGFEN0-1;

    (6) YOUZUGOUQIGUANGONGNENG,BIXUMANZUYIXIABIAOZHUN:

    血液:中性粒细胞绝对计数(ANC) ≥1.5×109/L(1500/mm3),血小板 ≥100×109/L,血红蛋白≥9 g/dL(90g/L)(筛查前 14 天内未输血、未使用粒细胞集落刺激因子);

    赢红包的游戏大厅,赢红包的游戏大厅APP下载NINGXUEGONGNENG:NINGXUEMEIYUANSHIJIANGUOJIBIAOZHUNHUABIZHIQIEBUFENNINGXUEHUOMEISHIJIAN≤1.5BEIZHENGCHANGZHISHANGXIAN(ULN);

    GANZANG:RUOWUMINGQUEDEGANZHUANYI,XUEQINGZONGDANHONGSU≤1.5 ULN,MENDONGANSUANANJIZHUANYIMEI(AST)HEBINGANSUANANJIZHUANYIMEI(ALT) ≤3.0 ULN;RUOYOUGANZHUANYI,ASTHEALT ≤5.0 ULN,ZONGDANHONGSU≤ 3.0 ULN;RUOYOUMINGQUEDEGilbertZONGHEZHENG(FEIJIEHEXINGGAODANHONGSUXUEZHENG),ZONGDANHONGSU≤ 3.0 ULN;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载SHENZANG:XUEQINGJIGAN(Scr)≤1.5 ULN,HUOJIGANQINGCHULV(Ccr)≥60ml/min(GENJUCockcroft and GaultGONGSHI);

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(7) JIWANGKANGZHONGLIUZHILIAOHUOWAIKESHOUSHUDESUOYOUJIXINGDUXINGFANYINGHUANJIEZHIJIXIANYANZHONGCHENGDUHUONCI CTCAE BANBEN4.03 ≤1 JI(TUOFAHUOYANJIUZHERENWEIDUIHUANZHEWUANQUANFENGXIANDEQITADUXINGCHUWAI);

    (8) DUIYUJUEJINGQIANYOUSHENGYUKENENGDEFUNVBIXUZAIKAISHIZHILIAOZHIQIANDE7TIANNEIZUORENSHENSHIYAN,XUEQINGRENSHENSHIYANBIXUWEIYINXING,BIXUWEIFEIBURUQI;SUOYOURUZUHUANZHEJUNYINGZAIZHENGGEZHILIAOQIJIANJIZHILIAOJIESHUHOU3GEYUECAIQUYIXUERENKEDEBIYUNCUOSHI;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(9) ZIYUANRUZUBINGQIANSHUZHIQINGTONGYISHU,ZUNXUNSHIYANZHILIAOFANGANHEFANGSHIJIHUA。

    排除标准:

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(1) JIESHOUYANJIUYAOWUQIAN28TIANNEI(DUIYUGUSUIYIZHIYAOWUHUOZHILIAO)HUO14TIANNEI(DUIYUFEIGUSUIYIZHIYAOWUHUOZHILIAO)CENGJIESHOUQITAKANGZHONGLIUZHILIAO(BAOKUOHUALIAO、FANGLIAO、MIANYIZHILIAOHESHIYANXINGZHILIAO);

    (2) 既往接受过其他CDK4/6抑制剂的治疗,如Abemaciclib(VERZENIO™,LY2835219)、Palbociclib(IBRANCE®,PD0332991)、Ribociclib(KISQALI® ,LEE-011)、吡罗西尼(Birociclib,XZP-3287)、SHR-6390、Trilaciclib和G1T-38等;

    (3) FUHEXIALIERENYIXINZANGBIAOZHUN:WUFAJIESHIHUOXINXUEGUANYUANYINDAOZHIDEXIANZHAOYUNJUEHUOYUNJUE、SHIXINGXINDONGGUOSU、XINSHIXIANZHANHUOXINZANGZHOUTING。XIAOZHENGQTJIANQIYANZHANG【ZAIJINGXIZHUANGTAIXIA,3CIXINDIANTU(ECG)JIANCHADECHUDEPINGJUNXIAOZHENGQTJIANQI(NANXINGQTcF>450msecHUONVXINGQTcF>470msec)】。GEZHONGYOULINCHUANGYIYIDEXINLV、CHUANDAO、JINGXIECGXINGTAIYICHANG,LIRUWANQUANXINGZUOSHUZHICHUANDAOZUZHI,IIIDUCHUANDAOZUZHI,IIDUCHUANDAOZUZHI,PRJIANQI>250 msec;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(4) YOULINCHUANGYIYIDEHUODONGXINGXIJUN、ZHENJUNHUOBINGDUGANRAN(LIRUHUODONGXINGYIXINGGANYAN(HBV),BINGXINGGANYAN(HCV)、RENLEIMIANYIQUEXIANBINGDU(HIV)HEMEIDUYANGXING,RUXUANSHIBUYAOQIUDUIQITAHUODONGXINGGANRANJINXINGSHAICHA);

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(5) JIESHOUGUOZITIHUOTONGZHONGYITIQIGUANHUOGANXIBAOYIZHISHOUSHU;ZAISHOUCIYONGYAOQIAN4ZHOUNEIJINXINGGUODASHOUSHUHUOYANZHONGWAISHANGDEHUANZHE;

    (6) ZAIJINRUYANJIUZHIQIANDE7 TIANNEIHUANZHEJIESHOUGUOYIXIAZHILIAO:YIZHISHIZHONGXIAOHUOQIANGXIAODECYP3AYIZHIJIHUOYOUDAOJI,YIJIZHUYAOTONGGUOCYP2C19 DAIXIEDEYAOWU;HUOSHIYONGGUOXIYOUHEXIYOUZHI;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(7) YANJIUZHILIAOSHOUCIJIYAOQIAN1ZHOUNEIJIESHOUZHONGCAOYAOKANGZHONGLIUZHILIAODEHUANZHE;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(8) YOUYUANFACNSEXINGZHONGLIU。JINGJUBUZHILIAOSHIBAIDECNSZHUANYIHUANZHE。DUIYUWUZHENGZHUANGNAOZHUANYI、HUOLINCHUANGZHENGZHUANGWENDINGQIEWUXULEIGUCHUNJISUHEQITAZHENDUINAOZHUANYIZHILIAO≥28TIANDEHUANZHEKEYIRUZU;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(9) GUOQU5NIANNEICENGHUANYOUQITAEXINGZHONGLIU,DANJINGGUOGENZHIXINGZHILIAODEPIFUJIDIXIBAOAIHEGONGJINGYUANWEIAICHUWAI;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(10) SHOUCIYONGYAOQIAN6GEYUENEIFASHENGDONG/JINGMAIXUESHUANSHIJIAN,RUNAOXUEGUANYIWAI(BAOKUODUANZANXINGNAOQUEXUEFAZUO、NAOCHUXUE、NAOGENGSAI)、SHENJINGMAIXUESHUANJIFEISHUANSAIDENG;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(11) YIZHICUNZAIDEJIAZUXINGHE/HUOHUODEXINGXUESHUANQINGXIANG,RUCUNZAIKANGNINGDANBAI、NINGXUEYINZI、XIANRONGDANBAIDENGYICHUANXINGHUOHUODEXINGQUEXIAN,HUOZHECUNZAIHUODEXINGWEIXIANYINSUERJUYOUGAOXUESHUANSHUANSAIQINGXIANG;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(12) RENHEYINGXIANGHUANZHETUNFUYAOWUDEQINGKUANG,YIJIYANZHONGYINGXIANGSHIYANYAOWUXISHOUHUOYAODAIDONGLIXUECANSHUDEQINGKUANG,BAOKUONANYIKONGZHIDEEXINOUTU、MANXINGWEICHANGDAOJIBING,WEICHANGDAOQIECHUHUOSHOUSHUSHIDENG;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(13) YIZHIDUIYANJIUYAOWUHUORENYIFULIAOYANZHONGGUOMIN;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(14) CUNZAILANYONGYAOWUYIJIYIXUE、XINLIXUEHUOSHEHUITIAOJIANKENENGGANRAOCANYUYANJIUHUODUIYANJIUJIEGUOPINGGUCHANSHENGYINGXIANGDEHUANZHE;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(15) RENHEBUWENDINGDEXITONGXINGJIBING(BAOKUOHUODONGQIDE≥CTCAE 2JIDELINCHUANGYANZHONGGANRAN、YAOWUWUFAKONGZHIDEGAOXUEYA、BUWENDINGXINJIAOTONG、CHONGXUEXINGXINLISHUAIJIE、YANZHONGDEGANSHENHUODAIXIEXINGJIBINGDENG);

    (16) RENHEBUWENDINGDEHUOKENENGWEIJIHUANZHEANQUANXINGJIQIDUIYANJIUDEYICONGXINGDEZHUANGKUANG;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载(17) YANJIUZHERENWEIBUSHIHECANJIABENSHIYANDEQITAQINGKUANG。

    研究者信息

    研究者信息.jpg

  • BPI-23314在复发/难治性急性髓系白血病患者中的I期临床研究
    产品情况

    BPI-23314SHIBEIDAZIZHUYANFADEYONGYOUWANQUANZIZHUZHISHICHANQUANDEXINFENZIHUAHEWU,SHIYIZHONGJUYOUQUANXINJIEGOUDEQIANGXIAO、GAOXUANZEXINGXIUJIEGOUYUHEMODUANWAIJIEGOUYU(Bromodomain and extra-terminal domain, BET)KOUFUXIAOFENZIYIZHIJI。BPI-23314NENGTONGGUOTEYIXINGYIZHIBETJIAZUDANBAIDEGONGNENG,DIAOKONGAIZHENGXIANGGUANJIYINDEZHUANLUBIAODA,JINERYINGXIANGXIBAOSHENGZHANG、ZENGZHI、DIAOWANGDENGDUOGESHENGLIGUOCHENG,ZUIZHONGDADAOYIZHIZHONGLIUSHENGZHANGDEMUBIAO。

    试验信息

    试验目的

    ZHUYAOMUDE:PINGGUBPI-23314PIANZAIFUFA/NANZHIXINGJIXINGSUIXIBAIXUEBINGHUANZHEDEANQUANXINGHENAISHOUXING;TANSUOZUIDANAISHOUJILIANG(MTD),QUEDING2QIYANJIUTUIJIANJILIANG(RP2D)。 

    CIYAOMUDE:PINGJIABPI-23314PIANDEYAODAIDONGLIXUETEZHENG;PINGGUBPI-23314PIANDECHUBULIAOXIAO。


    SHIYANFENLEI:ANQUANXINGHENAISHOUXING

    SHIYANFENQI:IQI

    SHEJILEIXING:(1)JILIANGDIZENGYANJIU:CAIYONG“3+3”DESHIYANSHEJI (2)KUODARUZUYANJIU

    SUIJIHUA:FEISUIJIHUA

    MANGFA:KAIFANG

    SHIYANFANWEI:GUONEISHIYAN

    RUZURENSHU:36REN


    入选标准:

    1.GENJUSHIJIEWEISHENGZUZHI(WHO)BIAOZHUNQUEZHENDEJIXINGSUIXIBAIXUEBINGDEFUFA/NANZHIHUANZHE,FUHEYIXIARENYITIAOJIAN: i. 12GEYUEYINEIFUFA; ii. JINGBIAOZHUNFANGANYOUDAOLIANGGELIAOCHENGHOUWEIHUOWANQUANHUANJIEDENANZHIXINGAMLHUANZHE;

    2.NIANLINGWEI18-70SUI(HANBIANJIENIANLING),XINGBIEBUXIAN;

    3.YUQISHENGCUN≥12ZHOU;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载4.MEIGUODONGBUZHONGLIUXIEZUOZU(ECOG)TINENGZHUANGTAIPINGFEN0-1;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载5.XUECHANGGUI:ZHENGCHANGQINGKUANGXIA,BAIXIBAOJISHU(WBC)≤20×10^9/L;HUOZHEHUANZHEZAISHIYONGQIANGJINIAOHUOATANGBAOGANQIANBAIXIBAOJISHU(WBC)>20×10^9/L,SHIYONGYIDUANSHIJIANBINGTINGYAO3TIANHOU,JIANCEBAIXIBAOJISHU(WBC)≤20×10^9/L;

    6.NINGXUEGONGNENG:NINGXUEMEIYUANSHIJIANGUOJIBIAOZHUNHUABIZHIQIEBUFENNINGXUEHUOMEISHIJIAN≤1.5BEIZHENGCHANGZHISHANGXIAN(ULN);

    7.GANZANG:RUOWUMINGQUEDEGANZHUANYI,XUEQINGZONGDANHONGSU≤1.5 ULN,MENDONGANSUANANJIZHUANYIMEI(AST)HEBINGANSUANANJIZHUANYIMEI(ALT) ≤2.5 ULN;RUOYOUMINGQUEDEGilbertZONGHEZHENG(FEIJIEHEXINGGAODANHONGSUXUEZHENG),ZONGDANHONGSU≤ 3.0 ULN;

    8.SHENZANG:XUEQINGJIGAN(Scr)≤1.5 ULN,HUOJIGANQINGCHULV(Ccr)≥60ml/min;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载9.JIWANGKANGZHONGLIUZHILIAOHUOWAIKESHOUSHUDESUOYOUJIXINGDUXINGFANYINGHUANJIEZHIJIXIANYANZHONGCHENGDUHUONCI CTCAE BANBEN4.03 ≤1 JI(TUOFA、XUEYEXUEHUOYANJIUZHERENWEIDUIHUANZHEWUANQUANFENGXIANDEQITADUXINGCHUWAI);

    10.DUIYUJUEJINGQIANYOUSHENGYUKENENGDEFUNVBIXUZAIKAISHIZHILIAOZHIQIANDE7TIANNEIZUORENSHENSHIYAN,XUEQINGRENSHENSHIYANBIXUWEIYINXING,BIXUWEIFEIBURUQI;SUOYOURUZUHUANZHEJUNYINGZAIZHENGGEZHILIAOQIJIANJIZHILIAOJIESHUHOU3GEYUECAIQUYIXUERENKEDEBIYUNCUOSHI;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载11.SHOUSHIZHEXUYUANYITIGONGZHILIAOQIANYIYOUDEYOUXIAOZHENDUANZHENGJUHUOJIESHOUGUSUIJIANCHA,HEZAIZHILIAOHOUJIESHOUGUSUIJIANCHA;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载12.ZIYUANRUZUBINGQIANSHUZHIQINGTONGYISHU,ZUNXUNSHIYANZHILIAOFANGANHEFANGSHIJIHUA。

    排除标准:

    赢红包的游戏大厅,赢红包的游戏大厅APP下载1.JIWANGJIESHOUGUOQITABRD4HUOBETYIZHIJIDEZHILIAO;

    2.ZAOYOULIXIBAOBAIXUEBINGHUANZHE;

    3.JIWANGJIESHOUGUOGUSUIYIZHIXINGHUALIAO(CHUATANGBAOGANHEQIANGJINIAOWAI)、XIAOFENZIYAOWUZHILIAODE,QIZHONGZHIZHILIAOSHIJIANJULISHOUCIYONGYAOSHAOYU4ZHOUHUO5GEBANSHUAIQINEI(QUSHIJIANZHANGZHE);

    4.JIWANGJIESHOUGUOSHENGWUZHILIAOHE/HUOMIANYIZHILIAO,QIZHONGZHIZHILIAOSHIJIANJULISHOUCIYONGYAOSHAOYU8ZHOUHUO5GEBANSHUAIQINEI(QUSHIJIANZHANGZHE);

    5.SHOUCIYONGYAOQIAN1ZHOUNEIJIESHOUZHONGCAOYAOKANGZHONGLIUZHILIAODEHUANZHE;

    6.GUOQU5NIANNEICENGHUANYOUQITAEXINGZHONGLIU,DANJINGGUOGENZHIXINGZHILIAODEPIFUJIDIXIBAOAIHEGONGJINGYUANWEIAICHUWAI;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载7.ZHONGLIULEIJIZHONGSHUSHENJINGXITONGHELEIJIGAOWAN;

    8.SHOUCIYONGYAOQIAN3GEYUENEIJIESHOUGUOZITIGANXIBAOYIZHISHOUSHU;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载9.JIESHOUGUOYITIQIGUANHUOGANXIBAOYIZHISHOUSHU;

    10.SHOUCIYONGYAOQIAN4ZHOUNEIJINXINGGUODASHOUSHUHUOYANZHONGWAISHANGDEHUANZHE;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载11.SHOUCIYONGYAOQIAN6GEYUENEIFASHENGDONG/JINGMAIXUESHUANSHIJIAN;

    12.YIZHICUNZAIDEJIAZUXINGHE/HUOHUODEXINGXUESHUANQINGXIANG,RUCUNZAIKANGNINGDANBAI、NINGXUEYINZI、XIANRONGDANBAIDENGYICHUANXINGHUOHUODEXINGQUEXIAN,HUOZHECUNZAIHUODEXINGWEIXIANYINSUERJUYOUGAOXUESHUANSHUANSAIQINGXIANG;

    13.ZHONGYAOQIGUANYOUCHUXUEQINGXIANGHUOHUODONGXINGCHUXUEZHE;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载14.RENHEYANZHONGDEHE/HUOWEINENGKONGZHIDEXITONGXINGJIBING;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载15.WUFAJIESHIHUOXINXUEGUANYUANYINDAOZHIDEXIANZHAOYUNJUEHUOYUNJUE、SHIXINGXINDONGGUOSU、XINSHIXIANZHANHUOXINZANGZHOUTING;

    16.XIAOZHENGQTJIANQIYANZHANG【ZAIJINGXIZHUANGTAIXIA,3CIXINDIANTU(ECG)JIANCHADECHUDEPINGJUNXIAOZHENGQTJIANQI(NANXINGQTcF>450msecHUONVXINGQTcF>470msec)】;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载17.GEZHONGYOULINCHUANGYIYIDEXINLV、CHUANDAO、JINGXIECGXINGTAIYICHANG;

    18.RENLEIMIANYIQUEXIANBINGDU(HIV)GANRAN,MEIDUGANRAN,HUODONGXINGHBVGANRAN,HCVGANRAN;

    19.RENHEYINGXIANGHUANZHETUNFUYAOWUDEQINGKUANG,YIJIYANZHONGYINGXIANGSHIYANYAOWUXISHOUHUOYAODAIDONGLIXUECANSHUDEQINGKUANG;

    20.SHOUCIJIYAOQIAN7 TIANNEIHUANZHEJIESHOUGUOYIXIAZHILIAO:YIZHISHICYP1A2QIANGXIAOYIZHIJIHUOYOUDAOJI;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载21.YANJIUQIJIANBUNENGZHONGDUANSHIYONGCYP2C9 DIWU;

    22.SHOUCIJIYAOQIAN7TIANNEIHUANZHEJIESHOUGUOXUJINGOATP1B1ZHUANYUNTIZHUANYUNDEYAOWU;

    23.CUNZAILANYONGYAOWUYIJIYIXUE、XINLIXUEHUOSHEHUITIAOJIANKENENGGANRAOCANYUYANJIUHUODUIYANJIUJIEGUOPINGGUCHANSHENGYINGXIANGDEHUANZHE;

    赢红包的游戏大厅,赢红包的游戏大厅APP下载24.YIZHIDUIYANJIUYAOWUHUORENYIFULIAOYANZHONGGUOMIN;

    25.RENHEBUWENDINGDEHUOKENENGWEIJIHUANZHEANQUANXINGJIQIDUIYANJIUDEYICONGXINGDEZHUANGKUANG;

    26.YANJIUZHERENWEIBUSHIHECANJIABENSHIYANDEQITAQINGKUANG。

    研究者信息

    研究者信息.jpg

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