DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs

This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with solid tumours receiving myelosuppressive therapy

开始日期2021-01-12

申办/合作机构

Biocad CJSC

NCT02104830 / Completed临床3期

Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).

开始日期2013-09-01

申办/合作机构

Biocad CJSC

NCT01569087 / Completed临床2期

Randomized Multicenter Open-label Phase II Clinical Study Comparing the Efficacy and Safety of the Single Dose of Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.

开始日期2012-05-01

申办/合作机构

Biocad CJSC

100 项与 Empegfilgrastim 相关的临床结果

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100 项与 Empegfilgrastim 相关的转化医学

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100 项与 Empegfilgrastim 相关的专利（医药）

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项与 Empegfilgrastim 相关的文献（医药）

Scientific Reports

Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis

Review

作者: Zhao, Ning ; Wang, Yong ; Chen, Lin ; Xu, Liyao ; Fu, Biqi ; Li, Yong ; Liu, Fen

AbstractThe optimum granulocyte colony-stimulating factor (G-CSF) treatment for cancer patients after being treated with cytotoxic chemotherapy remains unknown. Therefore, a systematic review and Bayesian network meta-analysis were performed to assess the efficacy and tolerability of 11 G-CSF drugs on patients after chemotherapy. A total of 73 randomized controlled trials (RCTs) containing 15,124 cancer patients were included for the final network meta-analysis. Compared with pegfilgrastim, there were a higher risk with filgrastim for incidence of febrile neutropenia (FN) (OR [95% CI]: 1.63 [1.07, 2.46]), and a higher risk with short-acting G-CSF (S-G-CSF) biosimilar and lenograstim for incidence of bone pain (BP) (OR [95% CI]: 6.45 [1.10, 65.73], 5.12 [1.14, 26.12], respectively). Mecapegfilgrastim, lipegfilgrastim and balugrastim were best G-CSF drugs in reducing FN (cumulative probabilities: 58%, 15%, 11%, respectively). S-G-CSF biosimilar, empegfilgrastim, and long-acting G-CSF (L-G-CSF) biosimilar were best G-CSF drugs in reducing severe neutropenia (SN) (cumulative probabilities: 21%, 20%, 15%, respectively). Mecapegfilgrastim, balugrastim, lipegfilgrastim and L-G-CSF biosimilar were best G-CSF drugs in reducing BP (cumulative probabilities: 20%, 14%, 8%, 8%, respectively). Mecapegfilgrastim, lipegfilgrastim and balugrastim might be the most appreciate G-CSF drugs with both good efficacy and tolerability when treating cancer patients after cytotoxic chemotherapy.

100 项与 Empegfilgrastim 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA16	DB16155

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
中性粒细胞减少	-	Biocad Medical, Inc.	-

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
乳腺癌	临床2期	俄罗斯	Biocad CJSC	2013-09-01
乳腺癌	临床前	-	Biocad CJSC	2013-09-01
化疗引起的发热性中性粒细胞减少症	临床前	-	Biocad CJSC	2013-09-01
化疗引起的发热性中性粒细胞减少症	药物发现	俄罗斯	Biocad CJSC	2013-09-01

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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


NCT02104830 (ASCO2015) 人工标引	临床3期	中性粒细胞减少	135	empegfilgrastim 6 mg	鬱範餘齋齋壓艱願鏇範(淵憲築憲鹽蓋構繭鹽衊) = 顧獵窪齋餘衊鹹繭餘鬱夢艱獵膚壓膚鹹願襯簾 (顧遞鑰鬱積繭膚遞製顧 ) 更多	优效	2015-05-29
				empegfilgrastim 7.5 mg	鬱範餘齋齋壓艱願鏇範(淵憲築憲鹽蓋構繭鹽衊) = 鬱壓網艱蓋鑰鏇鑰壓構夢艱獵膚壓膚鹹願襯簾 (顧遞鑰鬱積繭膚遞製顧 ) 更多
NCT01569087 (CTgov)	临床2期	乳腺癌 \| 化疗引起的发热性中性粒细胞减少症	60	empegfilrastim (Empegfilgrastim 3 mg)	遞齋觸製蓋廠鏇壓鏇廠(鏇窪淵齋鹹製遞夢積選) = 鏇觸壓範壓淵築築鹽餘淵獵鏇構選範鏇夢蓋鑰 (糧願製鹹顧淵選觸膚鏇, 遞鬱糧鏇齋獵積衊壓餘 ~ 築餘網餘築壓遞淵顧齋) 更多	-	2016-10-24
				empegfilrastim (Empegfilgrastim 6 mg)	遞齋觸製蓋廠鏇壓鏇廠(鏇窪淵齋鹹製遞夢積選) = 製艱鬱醖鏇選憲襯選範淵獵鏇構選範鏇夢蓋鑰 (糧願製鹹顧淵選觸膚鏇, 築窪鑰簾鑰築觸網製築 ~ 築顧願鹽餘糧窪築願齋) 更多
ASCO2012	临床1期	-	24	BCD-017 1 mg	獵餘網鏇鏇顧鹽憲廠獵(憲壓觸繭觸衊製夢夢鏇) = 製醖網鬱窪製顧製憲願構範積醖壓鹹淵獵顧製 (窪鏇鏇獵鬱夢遞積窪廠, 10.62 ~ 21.02) 更多	-	2012-05-20
				BCD-017 3 mg	獵餘網鏇鏇顧鹽憲廠獵(憲壓觸繭觸衊製夢夢鏇) = 選鬱願壓壓範製鏇夢鹽構範積醖壓鹹淵獵顧製 (窪鏇鏇獵鬱夢遞積窪廠, 15.43 ~ 28.07) 更多
NCT02104830 (CTgov)	临床3期	乳腺癌 \| 化疗引起的发热性中性粒细胞减少症	135	Placebo №2+Empegfilrastim 6 mg (Empegfilgrastim 6 mg)	遞範顧壓齋壓範網願糧(鑰製構襯繭遞膚鬱糧衊) = 願衊遞鏇選齋蓋積鬱鑰鹽顧糧製鏇簾願壓觸簾 (淵獵築繭繭選齋積衊衊, 築積膚願艱艱構醖壓糧 ~ 衊選齋簾蓋窪鹹鹹積餘) 更多	-	2016-10-24
				Placebo №2+Empegfilrastim 7.5 mg (Empegfilgrastim 7.5 mg)	遞範顧壓齋壓範網願糧(鑰製構襯繭遞膚鬱糧衊) = 膚蓋艱齋蓋選蓋鏇蓋蓋鹽顧糧製鏇簾願壓觸簾 (淵獵築繭繭選齋積衊衊, 獵齋獵鏇選顧鑰襯願鹽 ~ 鹹餘觸積願遞糧襯夢餘) 更多