Randomized, double-blind, parallel group, placebo-controlled, dose finding study in colorectal cancer patients receiving 5-FU-based chemotherapy to assess the efficacy of different doses of s.c. elsiglutide in the prevention of Chemotherapy Induced Diarrhea (CID)

开始日期-

申办/合作机构

Helsinn Healthcare SA

NCT02383810 / Completed临床2期

Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Different Doses of s.c. Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)

This is a randomized, stratified, double-blind, double-dummy, parallel group, placebo-controlled, dose finding, multicentre, multinational, phase II study in patient with colorectal cancer receiving 5- Fluorouracil (5-FU)-based chemotherapy (FOLFOX or FOLFIRI). Patients will receive, starting from the day of chemotherapy administration, a single daily dose subcutaneously (s.c.) of elsiglutide 10, 20 or 40 mg or placebo for 4 consecutive days. Each patient will be in the study for 3 consecutive chemotherapy cycles. The treatment period for each patient will be 4 consecutive days at each of the first 2 chemotherapy cycles.
The primary objective is to compare the efficacy of 3 s.c. doses of elsiglutide versus (vs.) placebo and vs. each other dose in the prevention of CID in colorectal cancer patients treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI) with no addition of a monoclonal antibody.

开始日期2015-01-01

申办/合作机构

Helsinn Healthcare SA

[+1]

NCT01543451 / Completed临床2期

Phase II, Double-blind, Randomized, Two-stage, Placebo-controlled Proof of Concept Study in Colorectal Cancer Patients Receiving 5-FU Based Chemotherapy to Assess the Efficacy of Elsiglutide (ZP1846)Administered s.c. in the Prevention of Chemotherapy Induced Diarrhea(CID)

The main objective of this study will be to obtain data on the efficacy of elsiglutide in preventing Chemotherapy Induced Diarrhea (CID) in patients with colorectal cancer receiving 5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.

开始日期2012-02-01

申办/合作机构

Helsinn Healthcare SA

100 项与艾西糖肽相关的临床结果

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100 项与艾西糖肽相关的转化医学

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100 项与艾西糖肽相关的专利（医药）

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项与艾西糖肽相关的文献（医药）

2020-04-01·Cancer Chemotherapy and Pharmacology4区 · 医学

The GLP-2 analogue elsiglutide reduces diarrhoea caused by the tyrosine kinase inhibitor lapatinib in rats

4区 · 医学

Article

作者: Bateman, Emma ; Keefe, Dorothy M ; Pietra, Claudio ; Bowen, Joanne M ; Wignall, Anthony D ; Mayo, Bronwen J ; Thorpe, Daniel ; Secombe, Kate R

PURPOSELapatinib is a small molecule tyrosine kinase inhibitor used to treat breast cancer, often in combination with chemotherapy. Diarrhoea commonly occurs in up to 78% of patients undertaking lapatinib treatment. The mechanism of this diarrhoea is currently unknown. Elsiglutide is a GLP-2 analogue known to increase cell proliferation and reduce apoptosis in the intestine.METHODSWe used a previously developed rat model of lapatinib-induced diarrhoea to determine if co-treatment with elsiglutide was able to reduce diarrhoea caused by lapatinib. Additionally, we analysed the caecal microbiome of these rats to assess changes in the microbiome due to lapatinib.RESULTSRats treated with lapatinib and elsiglutide had less severe diarrhoea than rats treated with lapatinib alone. Serum lapatinib levels, blood biochemistry, myeloperoxidase levels and serum limulus amebocyte lysate levels were not significantly different between groups. Rats treated with lapatinib alone had significantly higher histopathological damage in the ileum than vehicle controls. This increase was not seen in rats also receiving elsiglutide. Rats receiving lapatinib alone had lower microbial diversity than rats who also received elsiglutide.CONCLUSIONSElsiglutide was able to reduce diarrhoea from lapatinib treatment. This does not appear to be via reduction in inflammation or barrier permeability, and may be due to thickening of mucosa, leading to increased surface area for fluid absorption in the distal small intestine. Microbial changes seen in this study require further research to fully elucidate their role in the development of diarrhoea.

100 项与艾西糖肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06336

研发状态

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
腹泻	临床2期	-	Zealand Pharma A/S	-
腹泻	临床1期	波兰	Helsinn Healthcare SA	-
腹泻	临床1期	白俄罗斯	Helsinn Healthcare SA	-
腹泻	临床1期	乌克兰	Helsinn Healthcare SA	-
腹泻	临床1期	德国	Helsinn Healthcare SA	-
腹泻	临床1期	俄罗斯	Helsinn Healthcare SA	-
腹泻	临床1期	捷克	Helsinn Healthcare SA	-
药物引起的腹泻	药物发现	匈牙利	Helsinn Healthcare SA	2012-02-01
药物引起的腹泻	药物发现	罗马尼亚	Helsinn Healthcare SA	2012-02-01
药物引起的腹泻	药物发现	-	Helsinn Healthcare SA	2012-02-01

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临床结果

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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


NCT02383810 (CTgov)	临床2期	药物引起的腹泻 \| 结直肠癌	498	Elsiglutide (Elsiglutide 10 mg - Target Population)	(範構壓簾網糧鏇獵顧鬱) = 餘廠鏇淵夢簾鹽繭襯網積顧繭範積選簾選鑰鬱 (鑰淵網餘範願膚齋鏇鹹, 廠蓋鏇繭艱鏇糧衊遞糧 ~ 蓋鹹鑰鬱糧構襯願選顧) 更多	-	2024-03-01
				Elsiglutide (Elsiglutide 20 mg - Target Population)	(範構壓簾網糧鏇獵顧鬱) = 鑰醖餘鹹齋選構網夢餘積顧繭範積選簾選鑰鬱 (鑰淵網餘範願膚齋鏇鹹, 夢鏇齋醖築顧窪餘簾網 ~ 憲膚選窪範願築範鏇淵) 更多
EUCTR2014-000998-39-HU (ASCO2017)	N/A	结直肠癌	484	Placebo	築築窪鹽遞蓋夢繭鑰衊(壓繭鏇鹽淵窪衊網構蓋) = Reduction of citrulline levels was smaller with elsiglutide compared with placebo 淵淵鹽糧鏇構鹽齋簾顧 (鹹夢鏇襯簾蓋簾築網憲 )	-	2017-05-30
				Elsiglutide 10 mg