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大冢制药的guadecitabine未达到一线治疗AML的III期研究的主要终点

2018-08-01 MedSci MedSci原创

GuadecitabineAML大冢制药
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大冢制药公司近日表示，guadecitabine在治疗先前未治疗的成人急性髓性白血病（AML）（这些成人患者不适合进行强化诱导化疗）的III期临床研究（ASTRAL-1研究）中未达到主要终点。结果表明，与对照组相比，下一代DNA低甲基化剂（guadecitabine，先前称为SGI-110）没有显著延长总体存活（OS）或改善完全应答率（ORR）。

大冢制药公司近日表示，guadecitabine在治疗先前未治疗的成人急性髓性白血病（AML）（这些成人患者不适合进行强化诱导化疗）的III期临床研究（ASTRAL-1研究）中未达到主要终点。结果表明，与对照组相比，下一代DNA低甲基化剂（guadecitabine，先前称为SGI-110）没有显著延长总体存活（OS）或改善完全应答率（ORR）。

大冢制药首席医疗官Mohammad Azab指出：“ASTRAL-1使用了非常严格的纳入和排除标准，这使得难以体现guadecitabine的优势”。该试验招募了815名未接受过AML治疗的成年患者，参与者被随机分配到皮下注射guadecitabine的治疗组或阿扎胞苷、地西他滨或低剂量阿糖胞苷组成的对照组。除了总体存活（OS）或改善完全应答率（ORR）等主要终点之外，次要终点还包括无进展生存、响应持续时间和安全性等。Astex解释说，对次要终点和安全性数据的评估正在进行中，而该研究的全部结果将在未来的研究会议上公布。该公司还表示，它正致力于完成guadecitabine治疗复发和难治性AML患者的III期ASTRAL-2试验，以及guadecitabine治疗复发和难治性骨髓增生异常综合征和慢性单核细胞白血病患者的ASTRAL-3试验。


原始出处：

http://www.firstwordpharma.com/node/1581956?tsid=28®ion_id=2#axzz5Mw2WiygQ

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    2019-05-25 juliusluan78

    #III#

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    2019-05-10 HinsMax

    #III期研究#

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    2018-11-23 12498877m109暂无昵称

    #CIT#

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  4. 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createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/qXbLjJB4FSzhQS3C5qQFMJkqicRIJFL6zHFwwhv0I95nzA6xicevQcEica0gk4A58UkbMMriadAgTY2b7N7Yd0ZsQg/132, createdBy=910c2500152, createdName=HinsMax, createdTime=Fri May 10 08:00:00 CST 2019, time=2019-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738535, encodeId=d8ae1e385356a, content=<a href='/topic/show?id=a9dd4e63c4' target=_blank style='color:#2F92EE;'>#CIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4763, encryptionId=a9dd4e63c4, topicName=CIT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eabf34462441, createdName=12498877m109暂无昵称, createdTime=Fri Nov 23 08:00:00 CST 2018, time=2018-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1981519, encodeId=05e519815196a, content=<a href='/topic/show?id=ec144360546' target=_blank style='color:#2F92EE;'>#大冢制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43605, encryptionId=ec144360546, topicName=大冢制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0a27288, createdName=smallant2002, createdTime=Mon Dec 10 01:00:00 CST 2018, time=2018-12-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1996939, encodeId=09f419969393f, content=<a href='/topic/show?id=b706232e831' target=_blank style='color:#2F92EE;'>#主要终点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23278, encryptionId=b706232e831, topicName=主要终点)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7387164, createdName=zhangj7108, createdTime=Sat Aug 11 06:00:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594528, encodeId=23c2159452822, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Aug 03 14:00:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588647, encodeId=4241158864e6e, content=<a href='/topic/show?id=57fe831e70' target=_blank style='color:#2F92EE;'>#Guadecitabine#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8317, encryptionId=57fe831e70, topicName=Guadecitabine)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bcac17601956, createdName=licz0429, createdTime=Fri Aug 03 14:00:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335941, encodeId=332a335941a1, content=学习了，谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Aug 03 07:22:54 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335909, encodeId=1e5233590982, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6d551998554, createdName=1e1c07bdm01(暂无匿称), createdTime=Fri Aug 03 06:26:37 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335736, encodeId=a3b6335e3678, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Aug 02 08:54:27 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-12-10 smallant2002

    #大冢制药#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1916028, encodeId=fbcf191602868, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sat May 25 10:00:00 CST 2019, time=2019-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021338, encodeId=b242202133857, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, 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style='color:#2F92EE;'>#大冢制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43605, encryptionId=ec144360546, topicName=大冢制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0a27288, createdName=smallant2002, createdTime=Mon Dec 10 01:00:00 CST 2018, time=2018-12-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1996939, encodeId=09f419969393f, content=<a href='/topic/show?id=b706232e831' target=_blank style='color:#2F92EE;'>#主要终点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23278, encryptionId=b706232e831, topicName=主要终点)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7387164, createdName=zhangj7108, createdTime=Sat Aug 11 06:00:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594528, encodeId=23c2159452822, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Aug 03 14:00:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588647, encodeId=4241158864e6e, content=<a href='/topic/show?id=57fe831e70' target=_blank style='color:#2F92EE;'>#Guadecitabine#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8317, encryptionId=57fe831e70, topicName=Guadecitabine)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bcac17601956, createdName=licz0429, createdTime=Fri Aug 03 14:00:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335941, encodeId=332a335941a1, content=学习了，谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Aug 03 07:22:54 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335909, encodeId=1e5233590982, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6d551998554, createdName=1e1c07bdm01(暂无匿称), createdTime=Fri Aug 03 06:26:37 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335736, encodeId=a3b6335e3678, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Aug 02 08:54:27 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-11 zhangj7108

    #主要终点#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1916028, encodeId=fbcf191602868, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sat May 25 10:00:00 CST 2019, time=2019-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021338, encodeId=b242202133857, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, 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style='color:#2F92EE;'>#大冢制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43605, encryptionId=ec144360546, topicName=大冢制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0a27288, createdName=smallant2002, createdTime=Mon Dec 10 01:00:00 CST 2018, time=2018-12-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1996939, encodeId=09f419969393f, content=<a href='/topic/show?id=b706232e831' target=_blank style='color:#2F92EE;'>#主要终点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23278, encryptionId=b706232e831, topicName=主要终点)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7387164, createdName=zhangj7108, createdTime=Sat Aug 11 06:00:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594528, encodeId=23c2159452822, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Aug 03 14:00:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588647, encodeId=4241158864e6e, content=<a href='/topic/show?id=57fe831e70' target=_blank style='color:#2F92EE;'>#Guadecitabine#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8317, encryptionId=57fe831e70, topicName=Guadecitabine)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bcac17601956, createdName=licz0429, createdTime=Fri Aug 03 14:00:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335941, encodeId=332a335941a1, content=学习了，谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Aug 03 07:22:54 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335909, encodeId=1e5233590982, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6d551998554, createdName=1e1c07bdm01(暂无匿称), createdTime=Fri Aug 03 06:26:37 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335736, encodeId=a3b6335e3678, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Aug 02 08:54:27 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-03 智智灵药

    #III期#

    0

  7. 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GetPortalCommentsPageByObjectIdResponse(id=1594528, encodeId=23c2159452822, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Aug 03 14:00:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588647, encodeId=4241158864e6e, content=<a href='/topic/show?id=57fe831e70' target=_blank style='color:#2F92EE;'>#Guadecitabine#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8317, encryptionId=57fe831e70, topicName=Guadecitabine)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bcac17601956, createdName=licz0429, createdTime=Fri Aug 03 14:00:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335941, encodeId=332a335941a1, content=学习了，谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Aug 03 07:22:54 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335909, encodeId=1e5233590982, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6d551998554, createdName=1e1c07bdm01(暂无匿称), createdTime=Fri Aug 03 06:26:37 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335736, encodeId=a3b6335e3678, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Aug 02 08:54:27 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-03 licz0429

    #Guadecitabine#

    0

  8. 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    2018-08-03 1209e435m98(暂无昵称)

    学习了，谢谢分享

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1916028, encodeId=fbcf191602868, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sat May 25 10:00:00 CST 2019, time=2019-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021338, encodeId=b242202133857, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, 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    2018-08-03 1e1c07bdm01(暂无匿称)

    好

    0

  10. 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    2018-08-02 清风拂面

    谢谢分享学习

    0

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