盐酸氨柔比星(Amrubicin Hydrochloride) - 药物靶点：DNA x Top II_在研适应症：非小细胞肺癌，小细胞肺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

AMR、Amrubicin、Amrubicin hydrochloride (JAN/USAN)

+ [5]

靶点

DNA x Top II

作用机制

DNA抑制剂(DNA抑制剂)、Top II抑制剂(拓扑异构酶II抑制剂)

治疗领域

肿瘤呼吸系统疾病

在研适应症

非小细胞肺癌小细胞肺癌

非在研适应症

晚期恶性实体瘤膀胱癌广泛期小细胞肺癌+ [7]

原研机构

Sumitomo Pharma Co., Ltd.

在研机构

Sumitomo Pharma Co., Ltd.

非在研机构

Celgene Corp.

最高研发阶段批准上市

首次获批日期

日本 (2002-04-11),

非小细胞肺癌小细胞肺癌

最高研发阶段(中国)无进展

特殊审评孤儿药 (美国)

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结构

分子式C25H25NO9

InChIKeyVJZITPJGSQKZMX-XDPRQOKASA-N

CAS号110267-81-7

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关联

68

项与盐酸氨柔比星相关的临床试验

JPRN-jRCT2061220036 / Recruiting临床2期

A Japanese phase II study to evaluate the efficacy and safety of combination therapy of amrubicin and durvalumab in patients with recurrent small cell lung cancer - Aphrodite study

开始日期2022-10-11

申办/合作机构-

JPRN-jRCT1071200033 / Recruiting临床1期

Phase I study of Amrubicin plus CISplatin and concurrent accelerated hyperfractionated thoracic radioTherapy for limited-disease small cell lung cancer - ACIST study

开始日期2020-10-02

申办/合作机构-

JPRN-UMIN000034657 / CompletedIIT

Amrubicin at a dose of 45mg/m2 with pegylated granulocyte-colony stimulating factor support in patients with previously treated small-cell lung cancer - A prospective observational study - - Amrubicin 45mg/m2 with pegylated granulocyte-colony stimulating factor support

开始日期2018-11-01

申办/合作机构-

100 项与盐酸氨柔比星相关的临床结果

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100 项与盐酸氨柔比星相关的转化医学

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100 项与盐酸氨柔比星相关的专利（医药）

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461

项与盐酸氨柔比星相关的文献（医药）

2024-03-01·IJU Case Reports

Metastatic small cell bladder cancer treated with sequential systemic therapy including pembrolizumab and amrubicin: A case report

作者: Wada, Koichiro ; Yokoyama, Shuhei ; Tsuboi, Ichiro ; Nakajima, Hirochika ; Tanaka, Gen ; Kobayashi, Yusuke ; Yosioka, Saori ; Nagami, Taichi ; Mitani, Kazutaka ; Ogawa, Kohei

IntroductionSmall cell bladder cancer is a relatively rare tumor, representing <1% of all bladder tumors. Amrubicin monotherapy is used as second‐line treatment for small cell lung cancer in Japan.Case presentationA 79‐year‐old woman presented with gross hematuria and was diagnosed with small cell bladder cancer (T2 or higher). Neoadjuvant chemotherapy with etoposide and cisplatin resulted in a partial response. Robot‐assisted radical cystectomy was performed, and radical resection was achieved. As we identified metastasis in the pleura 1 year later, we administered carboplatin and etoposide, which resulted in a partial response. Although pembrolizumab was initiated as maintenance therapy, it was not effective. Amrubicin was given as third‐line therapy, and stable disease was achieved without serious adverse effect for 6 months.ConclusionAlthough there is no established treatment for metastatic small cell bladder cancer, the current case report suggests the effectiveness of amrubicin in this setting.

2024-03-01·iScience

A safety screening platform for individualized cardiotoxicity assessment

Article

作者: Rivera-Arbeláez, José M ; Ribeiro, Marcelo C ; van der Zanden, Sabina Y ; Nollet, Edgar E ; van Boheemen, Chiara ; van der Velden, Jolanda ; Ten Den, Simone A ; Cofiño-Fabres, Carla ; Passier, Robert ; Cao, Lu ; Neefjes, Jacques ; Schwach, Verena ; Dannenberg, Maureen ; Slaats, Rolf H

Cardiotoxicity remains a major cause of drug withdrawal, partially due to lacking predictability of animal models. Additionally, risk of cardiotoxicity following treatment of cancer patients is treatment limiting. It is unclear which patients will develop heart failure following therapy. Human pluripotent stem cell (hPSC)-derived cardiomyocytes present an unlimited cell source and may offer individualized solutions to this problem. We developed a platform to predict molecular and functional aspects of cardiotoxicity. Our platform can discriminate between the different cardiotoxic mechanisms of existing and novel anthracyclines Doxorubicin, Aclarubicin, and Amrubicin. Doxorubicin and Aclarubicin unlike Amrubicin substantially affected the transcriptome, mitochondrial membrane integrity, contractile force and transcription factor availability. Cardiomyocytes recovered fully within two or three weeks, corresponding to the intermittent clinical treatment regimen. Our system permits the study of hPSC-cardiomyocyte recovery and the effects of accumulated dose after multiple dosing, allowing individualized cardiotoxicity evaluation, which effects millions of cancer patients treated annually.

2024-03-01·Journal of Medical Mycology

Pythium insidiosum: In vitro oomicidal evaluation of telithromycin and interactions with azithromycin and amorolfine hydrochloride

Article

作者: Pal, Mahendra ; Ianiski, Lara Baccarin ; Botton, Sônia de Avila ; Santurio, Janio Morais ; Maciel, Aline Fontanella ; Pereira, Daniela Isabel Brayer ; Braga, Caroline Quintana ; Sangioni, Luis Antônio ; Colla, Ana Carolina Nolasco

This study evaluated the repositioning of the ketolide antibacterial telithromycin (TLT) against the oomycete Pythium insidiosum and verified the combination of TLT and the antimicrobials azithromycin (AZM) and amorolfine hydrochloride (AMR), which have known anti-P. insidiosum activity. Susceptibility tests of P. insidiosum isolates (n = 20) against the drugs were carried out according to CLSI protocol M38-A2, and their combinations were evaluated using the checkerboard microdilution method. The minimum inhibitory concentrations were 0.5-4 µg/mL for TLT, 2-32 µg/mL for AZM, and 16-64 µg/mL for AMR. For the TLT+AZM combination, 52.75 % of interactions were indifferent, 43.44 % were antagonistic, and 9.70 % were synergistic. As for interactions of the TLT+AMR combination, 60.43 % were indifferent, 39.12 % were antagonistic, and 10.44 % synergistic interactions. This study is the first to evaluate the repositioning of the antibacterial TLT against mammalian pathogenic oomycetes, and our results show that its isolated action is superior to its combinations with either AZM or AMR. Therefore, we recommend including TLT in future research to evaluate therapeutic approaches in different clinical forms of human and animal pythiosis.

100 项与盐酸氨柔比星相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07100	盐酸氨柔比星	L01DB10	DB06263

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
非小细胞肺癌	日本	Sumitomo Pharma Co., Ltd.	2002-04-11
小细胞肺癌	日本	Sumitomo Pharma Co., Ltd.	2002-04-11

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
广泛期小细胞肺癌	临床2期	德国	Celgene Corp.	2007-09-01
广泛期小细胞肺癌	临床2期	保加利亚	Celgene Corp.	2007-09-01
广泛期小细胞肺癌	临床2期	波兰	Celgene Corp.	2007-09-01
广泛期小细胞肺癌	临床2期	匈牙利	Celgene Corp.	2007-09-01
小细胞肺癌	临床2期	欧盟	Celgene Corp.	-
广泛期小细胞肺癌	药物发现	荷兰	Celgene Corp.	2007-09-01
广泛期小细胞肺癌	药物发现	瑞士	Celgene Corp.	2007-09-01
广泛期小细胞肺癌	药物发现	-	Celgene Corp.	2007-09-01
广泛期小细胞肺癌	药物发现	意大利	Celgene Corp.	2007-09-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


MiSSION1 (ESMO2022)	N/A	广泛期小细胞肺癌二线	-	Amrubicin after ICI therapy	(鬱夢選糧糧網範憲顧齋) = 願願廠窪夢齋獵襯獵廠壓願鬱艱齋鬱鹽積觸網 (繭積願構膚淵鬱衊鹽範 ) 更多	-	2022-09-10
				Amrubicin without previous ICI treatment	(鬱夢選糧糧網範憲顧齋) = 鑰遞膚夢遞齋齋遞網鑰壓願鬱艱齋鬱鹽積觸網 (繭積願構膚淵鬱衊鹽範 ) 更多
NCT00890955 (Pubmed \| Am J Clin Oncol) 人工标引	临床1期	肿瘤	36	Cyclophosphamide+Amrubicin	(夢願構鏇廠鏇醖廠窪選) = cyclophosphamide 500 mg/m, AMR 30 mg/m 襯鬱齋顧鑰糧遞憲築窪 (積繭獵網鹽積膚遞夢壓 ) 更多	积极	2017-08-01
				Cyclophosphamide+Amrubicin (18 SCLC patients and 1 patient with extrathoracic small cell)
ASCO2022	N/A	小细胞肺癌复发二线	-	Topotecan	(醖獵願淵壓簾鏇壓構窪) = grade 3+ adverse events (AEs) were observed in 72%-96% and 74%-93% of patients with T (n = 308 from 3 studies) and A (n = 526 from 3 studies), respectively. The most common grade 3+ AEs in patients with L (n = 105) were neutropenia (46%) followed by leucopenia (29%) 夢齋夢簾構製鬱鏇網衊 (繭鬱簾遞壓壓鹽艱膚衊 )	-	2022-06-02
				Amrubicin
JPRN-UMIN000013882 (HOT1401/NJLCG1401, ESMO_ASIA2019)	临床2期	广泛期小细胞肺癌维持	34	Irinotecan	(積製鑰蓋壓獵齋窪壓糧) = 餘獵選醖選簾窪淵選獵淵構繭廠鬱壓遞構醖構 (淵憲範膚觸襯壓醖餘窪 ) 更多	-	2019-11-23
				Amrubicin	憲糧鹹鑰餘顧鹹積窪醖(餘襯製觸遞鬱繭選願襯) = 鹽鑰範積鑰簾鬱憲壓齋襯範製壓選淵觸糧範製 (齋鹽淵憲簾願願餘製糧, 31.4 ~ 63.2) 更多
JPRN-UMIN000006381 (ASCO2020)	临床2期	恶性胸膜间皮瘤二线	10	Amrubicin 35 mg/m2	(窪鏇襯鬱獵範鑰選鏇觸) = 餘積顧遞齋齋衊廠糧鹽鹽鏇廠衊齋衊艱獵顧餘 (壓顧糧築淵製網壓鏇蓋 ) 更多	积极	2020-05-25
NCT03253068 (Pubmed) 人工标引	临床2期	小细胞肺癌	25	amrubicin+Pembrolizumab	(醖襯製鬱膚遞網遞顧鹽) = 蓋艱鹽簾艱鏇顧鏇鹽願遞觸糧鑰蓋鹹齋艱觸構 (廠廠壓糧艱廠夢蓋憲蓋, 31.3 ~ 72.2) 更多	积极	2021-05-18
WCLC2019	N/A	非小细胞肺癌	27	Amrubicin	(網衊願餘膚構蓋蓋鬱淵) = 積艱壓衊鏇醖顧鏇構襯襯蓋範製製衊餘鹽餘襯 (網簾築憲衊糧獵觸獵壓 ) 更多	不佳	2019-09-08
WCLC2019	N/A	小细胞肺癌	8	Amrubicin	(範願簾觸繭鹹齋餘膚窪) = 鹽膚蓋膚鹹鑰壓艱範窪築獵餘範憲鑰窪鬱構製 (齋鹽網簾簾積選蓋顧淵 ) 更多	-	2019-09-09
				Cisplatin	(範願簾觸繭鹹齋餘膚窪) = 糧觸遞觸範觸繭醖築構築獵餘範憲鑰窪鬱構製 (齋鹽網簾簾積選蓋顧淵 )
WCLC2019	N/A	OCT6 SNP A146G	78	AMR	(網遞簾獵糧鹽衊壓夢窪) = 艱積餘繭衊糧選範繭範齋願顧範簾鏇構選廠艱 (餘齋醖淵選願獵鹹鏇繭 ) 更多	-	2019-09-08
NCT00660504 (Pubmed \| BMC Cancer) 人工标引	临床3期	广泛期小细胞肺癌一线	300	cisplatin+amrubicin	(襯積製壓齋糧醖窪繭繭) = 獵壓鬱夢膚憲築範鏇簾觸築積網憲簾廠遞積襯 (鹽鹹繭構衊積願憲廠鹹 ) 更多	非劣	2016-04-09
				cisplatin+etoposide	(襯積製壓齋糧醖窪繭繭) = 繭蓋遞襯壓糧齋醖鏇觸觸築積網憲簾廠遞積襯 (鹽鹹繭構衊積願憲廠鹹 ) 更多