巴芦格司亭(Balugrastim(Teva Biopharmaceuticals USA, Inc.)) - 药物靶点：CSF-3R_专利_临床

概要

基本信息

药物类型

融合蛋白

别名

Albugranin、Albumin fused G-CSF、Balugrastim

+ [8]

靶点

CSF-3R

作用方式

激动剂、刺激剂

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)、造血刺激剂

治疗领域

血液及淋巴系统疾病

在研适应症-

非在研适应症

中性粒细胞减少

原研机构

Teva Biopharmaceuticals USA, Inc.

在研机构-

非在研机构

Teva Pharmaceutical Industries Ltd.

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 9693373

来源: *****

关联

3

项与巴芦格司亭相关的临床试验

NCT01940601

/ Withdrawn临床2期

An Open Label, Randomized, Active Controlled, Dose Finding Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim at Doses of 300 µg/kg and 670 µg/kg in Pediatric Patients Diagnosed With Solid Tumors Receiving Chemotherapy

The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving chemotherapy.

开始日期2014-09-01

申办/合作机构

Teva Branded Pharmaceutical Products R&D, Inc.

EUCTR2012-005432-28-BG

/ Not yet recruitingN/A

An open label, randomized, active controlled, dose finding study to evaluate the pharmacodynamics, pharmacokinetics, efficacy and safety of balugrastim at doses of 300 µg/kg and 670 µg/kg in pediatric patients diagnosed with solid tumors receiving chemotherapy.

开始日期2013-10-23

申办/合作机构

Teva Pharmaceutical Industries Ltd.

NCT00837265

/ Completed临床2/3期

A Randomized Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)

Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

开始日期2008-08-21

申办/合作机构

Teva Branded Pharmaceutical Products R&D, Inc.

100 项与巴芦格司亭相关的临床结果

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100 项与巴芦格司亭相关的转化医学

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100 项与巴芦格司亭相关的专利（医药）

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12

项与巴芦格司亭相关的文献（医药）

2016-01-01·The Oncologist2区 · 医学

A Phase III Study of Balugrastim Versus Pegfilgrastim in Breast Cancer Patients Receiving Chemotherapy With Doxorubicin and Docetaxel

2区 · 医学

Article

作者: Moiseyenko, Vladimir ; Shparyk, Yaroslav ; Bondarenko, Igor N. ; Adar, Liat ; Gladkov, Oleg ; Avisar, Noa ; Barash, Steve

AbstractObjectives.This study aimed to evaluate the efficacy and safety of once-per-cycle balugrastim versus pegfilgrastim for neutrophil support in breast cancer patients receiving myelosuppressive chemotherapy.Methods.Breast cancer patients (n = 256) were randomized to 40 or 50 mg of subcutaneous balugrastim or 6 mg of pegfilgrastim ≈24 hours after chemotherapy (60 mg/m2 doxorubicin and 75 mg/m2 docetaxel, every 21 days for up to 4 cycles). The primary efficacy parameter was the duration of severe neutropenia (DSN) in cycle 1. Secondary parameters included DSN (cycles 2–4), absolute neutrophil count (ANC) nadir, febrile neutropenia rates, and time to ANC recovery (cycles 1–4). Safety, pharmacokinetics, and immunogenicity were assessed.Results.Mean cycle 1 DSN was 1.0 day with 40 mg of balugrastim, 1.3 with 50 mg of balugrastim, and 1.2 with pegfilgrastim (upper limit of 95% confidence intervals for between-group DSN differences was <1.0 day for both balugrastim doses versus pegfilgrastim). Between-group efficacy parameters were comparable except for time to ANC recovery in cycle 1 (40 mg of balugrastim, 2.0 days; 50 mg of balugrastim, 2.1; pegfilgrastim, 2.6). Median terminal elimination half-life was ≈37 hours for 40 mg of balugrastim, ≈36 for 50 mg of balugrastim, and ≈45 for pegfilgrastim. Antibody response to balugrastim was low and transient, with no neutralizing effect.Conclusion.Once-per-cycle balugrastim is not inferior to pegfilgrastim in reducing cycle 1 DSN in breast cancer patients receiving chemotherapy; both drugs have comparable safety profiles.

2015-06-01·Medical Oncology4区 · 医学

Phase II dose-finding study of balugrastim in breast cancer patients receiving myelosuppressive chemotherapy

4区 · 医学

Article

作者: Liat Adar ; Peter Bias ; Igor N. Bondarenko ; Oleg Gladkov ; Noa Avisar ; Vladimir Moiseyenko ; Steven Barash ; Yaroslav Shparyk

Balugrastim is a once-per-cycle, fixed-dose recombinant protein comprising human serum albumin and granulocyte colony-stimulating factor under development for prevention of severe neutropenia in cancer patients receiving myelosuppressive chemotherapy. This phase II, multicenter, active-controlled, dose-finding pilot study evaluated balugrastim safety and efficacy versus pegfilgrastim in breast cancer patients scheduled to receive myelosuppressive chemotherapy and investigated two doses with similar efficacy to pegfilgrastim for a subsequent phase III study. Patients received four cycles of doxorubicin/docetaxel chemotherapy and with each successive cycle were randomized sequentially to escalating doses of balugrastim [30 (n = 11), 40 (n = 21), or 50 mg (n = 20)] or a fixed dose of pegfilgrastim [6 mg (n = 26)] post-chemotherapy. Balugrastim doses were escalated as planned. The incidence of adverse events was similar among the balugrastim groups and between all balugrastim doses and pegfilgrastim. The most frequently reported adverse events were neutropenia, alopecia, and nausea. During cycle 1, severe neutropenia (absolute neutrophil count of <0.5 × 10(9)/L) occurred in 40, 67, and 50 % and febrile neutropenia occurred in 20.0, 9.5, and 10.0 % of patients receiving balugrastim 30, 40, and 50 mg, respectively; in patients receiving pegfilgrastim, 48 % experienced severe neutropenia and 8 % experienced febrile neutropenia. Duration of severe neutropenia (DSN) for each treatment group was 0.9, 1.6, 1.1, and 0.9 days, respectively. In the remaining three chemotherapy cycles, DSN was ≤1 day across all treatment groups. Balugrastim 50 mg was comparable to pegfilgrastim in terms of safety and overall efficacy in breast cancer patients receiving myelosuppressive chemotherapy.

2015-05-01·Cancer Chemotherapy and Pharmacology4区 · 医学

First-in-human, phase I/IIa dose-escalation and safety study of balugrastim in breast cancer patients receiving myelosuppressive chemotherapy

4区 · 医学

Article

作者: Udo Müller ; Liat Adar ; Jason Bock ; David Shen ; Laurie Pukac ; Noa Avisar ; Steve Barash

PURPOSETo evaluate safety of balugrastim, a recombinant human serum albumin and granulocyte colony-stimulating factor (G-CSF), administered over a range of therapeutic doses in women with breast cancer receiving doxorubicin plus docetaxel chemotherapy.METHODSThe phase I, sequential dose-escalation first segment compared subcutaneous balugrastim 50, 150, 300, and 450 µg/kg during chemotherapy cycles 0-2. The randomized (2:2:1), open-label, phase IIa second segment compared balugrastim 300 or 450 µg/kg with pegfilgrastim 6 mg during chemotherapy cycles 1 and 2.RESULTSIn the phase I segment, balugrastim was escalated to 450 µg/kg in 13 patients without dose-limiting toxicity. Three (9.7 %) of the 31 adverse events (AEs) reported in nine patients were grade 3 (agranulocytosis, vomiting, hypertension); none was grade 4. In the open-label phase IIa segment (N = 51), the majority of the 64 AEs reported in 31 (75.6 %) balugrastim-treated patients were grade 1 (59.4 %), with 39.1 % grade 2, 1.6 % grade 3 (one AE of vomiting), and none grade 4. Of the 16 AEs reported in seven (70.0 %) pegfilgrastim-treated patients, 87.5 % were grade 1, 6.3 % were grade 2, 6.3 % were grade 3 (one AE of thrombocytopenia), and none were grade 4. Overall, there were six bone pain AEs reported, one in the balugrastim 300 µg/kg group and five in the balugrastim 450 µg/kg group. No AEs in either study necessitated treatment interruption/discontinuation. The incidence and duration of grade 3-4 neutropenia were similar between balugrastim- and pegfilgrastim-treated patients.CONCLUSIONSBalugrastim was well tolerated in this small population of breast cancer patients.

100 项与巴芦格司亭相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10310	-	L03AA15	DB12699

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
中性粒细胞减少	临床3期	-	Teva Pharmaceutical Industries Ltd.	-

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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


ASCO2012	N/A	乳腺癌	-	Balugrastim 40 mg	(鬱顧鹹蓋膚簾範獵顧遞) = 襯蓋鹽範鹹顧觸餘憲構蓋鹹餘繭鏇鹹構膚淵選 (獵餘鹹構壓獵糧遞網憲 )	积极	2012-05-20
				Pegfilgrastim 6 mg	(鬱顧鹹蓋膚簾範獵顧遞) = 衊製蓋範築衊鬱網築餘蓋鹹餘繭鏇鹹構膚淵選 (獵餘鹹構壓獵糧遞網憲 )
ASCO2011	临床2/3期	乳腺癌	334	CG-10639 40mg	(醖壓積觸願憲夢襯艱壓) = 積窪醖繭齋齋齋蓋願製網憲糧餘遞構範廠獵遞 (製壓遞餘壓齋築範蓋壓 )	积极	2011-05-20
				CG-10639 50mg	(醖壓積觸願憲夢襯艱壓) = 餘顧鬱糧構築醖艱淵鑰網憲糧餘遞構範廠獵遞 (製壓遞餘壓齋築範蓋壓 )
SICOG 9908 (ASCO2004)	临床3期	转移性乳腺癌	132	PET (cisplatin 30 mg/m2/week + epirubicin 50 gm/m2/week + paclitaxel 120 mg/m2/week + G-CSF)	(憲蓋簾鹽觸淵築淵憲築) = Anaemia was substantially more frequent in the PET arm 壓鬱鹹廠廠膚襯鹹選製 (鏇鹽淵窪積餘簾遞築餘 ) 更多	积极	2004-07-15
				ET (epirubicin 90 mg/m2/ + paclitaxel 175 mg/m2)
SICOG 9908 (ASCO2004)	临床3期	局部晚期乳腺癌	160	PET (cisplatin 30 mg/m2/week + epirubicin 50 mg/m2/week + paclitaxel 120 mg/m2/week + G-CSF)	艱觸築鹹夢淵簾鑰顧鑰(鏇鬱網網鑰鏇蓋餘願鬱) = substantially more frequent in the PET arm 網壓餘觸網積選鏇製構 (選齋選齋鹽艱蓋淵願網 ) 更多	积极	2004-07-15
				ET (epirubicin 90 mg/m2/ + paclitaxel 175 mg/m2)