异环磷酰胺/美司钠(Ifosfamide/Mesna) - 在研适应症：出血性膀胱炎，睾丸肿瘤_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Ifex/Mesnex Kit

靶点-

作用方式-

作用机制-

治疗领域

肿瘤内分泌与代谢疾病泌尿生殖系统疾病

在研适应症

出血性膀胱炎睾丸肿瘤

非在研适应症-

原研机构

Baxter Healthcare Corp.

在研机构

Baxter Healthcare Corp.

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (1987-08-14),

出血性膀胱炎睾丸肿瘤

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C2H6NaO3S2

InChIKeyPYTISYCTLQTCTM-UHFFFAOYSA-N

CAS号19767-45-4

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关联

3

项与异环磷酰胺/美司钠相关的临床试验

NCT06236789

/ RecruitingN/AIIT

Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer

Prostate cancer is the 2nd most common cancer in men worldwide. Based on the results of several recent clinical trials, systemic treatments including hormone inhibitors, docetaxel, cabazitaxel, and PARP inhibitors are being used as standard treatment for patients with metastatic castration-resistant prostate cancer. However, there is insufficient research on salvage therapy for patients with metastatic castration-resistant prostate cancer who have failed standard treatment. In this study, the investigators will evaluate the effectiveness and safety of ifosfamide in castration-resistant prostate cancer by analyzing the treatment outcomes of patients who received ifosfamide/mesna treatment as salvage therapy.

开始日期2016-11-01

申办/合作机构

Yonsei University

NCT00823719

/ Completed临床2期

A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation

The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine, cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are eligible for autologous stem cell transplant.

开始日期2009-05-01

申办/合作机构

GSK Plc

NCT00137995

/ Completed临床3期IIT

Randomized Study of ICE Plus RITUXIMAB Versus DHAP Plus Rituximab in Previously Treated Patients With Diffuse Large B-cell Lymphoma, Followed by Randomized Maintenance With Rituximab

The primary objective of this study is to evaluate the efficacy and safety of induction therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma CD20.
The goal is to detect a difference in mobilization adjusted response rate of 15% between R-ICE and R-DHAP.
The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy after transplantation as measured by the event free survival.
The goal is to obtain a 15% increase of event free survival at 2 years.

开始日期2003-06-01

申办/合作机构

The Lymphoma Study Association

100 项与异环磷酰胺/美司钠相关的临床结果

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100 项与异环磷酰胺/美司钠相关的转化医学

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100 项与异环磷酰胺/美司钠相关的专利（医药）

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2

项与异环磷酰胺/美司钠相关的文献（医药）

1999-09-01·Annals of Oncology1区 · 医学

Saturable metabolism of continuous high-dose ifosfamide with Mesna and GM-CSF: A pharmacokinetic study in advanced sarcoma patients

1区 · 医学

Article

作者: P. Honegger ; S. Leyvraz ; T. von Briel ; A.V. Boddy ; S.-F. Hsu Schmitz ; A. Küpfer ; R. Schaad ; J. Brunner ; C. Sessa ; T. Cerny

BACKGROUNDThe aim of this study was to assess the pharmacology, toxicity and activity of high-dose ifosfamide mesna +/- GM-CSF administered by a five-day continuous infusion at a total ifosfamide dose of 12-18 g/m2 in adult patients with advanced sarcomas.PATIENTS AND METHODSBetween January 1991 and October 1992 32 patients with advanced or metastatic sarcoma were entered the study. Twenty-seven patients were pretreated including twenty-three with prior ifosfamide at less than 8 g/m2 total dose/cycle. In 25 patients (27 cycles) extensive pharmacokinetic analyses were performed.RESULTSThe area under the plasma concentration-time curve (AUC) for ifosfamide increased linearly with dose while the AUC's of the metabolites measured in plasma by thin-layer chromatography did not increase with dose, particularly that of the active metabolite isophosphoramide mustard. Furthermore the AUC of the inactive carboxymetabolite did not increase with dose. Interpatient variability of pharmacokinetic parameters was high. Dose-limiting toxicity was myelosuppression at 18 g/m2 total dose with grade 4 neutropenia in five of six patients and grade 4 thrombocytopenia in four of six patients. Therefore the maximum tolerated dose was considered to be 18 g/m2 total dose. There was one CR and eleven PR in twenty-nine evaluable patients (overall response rate 41%).CONCLUSIONBoth the activation and inactivation pathways of ifosfamide are non-linear and saturable at high-doses although the pharmacokinetics of the parent drug itself are dose linear. Ifosfamide doses greater than 14-16 g/m2 per cycle appear to result in a relative decrease of the active metabolite isophosphoramide mustard. These data suggest a dose-dependent saturation or even inhibition of ifosfamide metabolism by increasing high dose ifosfamide and suggest the need for further metabolic studies.

1986-01-01·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie2区 · 医学

CNS-side effects induced by Ifosfamide-Mesna in children with osteosarcomas.

2区 · 医学

Article

作者: Cornille, H ; Desbois, J G ; Delépine, G ; Jasmin, C ; Taillard, F ; Delépine, N

The authors have had the opportunity to see two cases of CNS side effects of Ifosfamide-Mesna association in children. Data in the medical literature about this subject remains poor. Only a few observations are available. In the referred cases, CNS side effects (lethargy, apathy and mutism) appeared a few hours after the second day of treatment and were spontaneously reversible in a few days. After reviewing possible mechanisms of this toxicity the authors pointed out the necessity to keep this type of side effects of Ifosfamide-Mesna association in mind, and to avoid it in susceptible patients.

100 项与异环磷酰胺/美司钠相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
出血性膀胱炎	美国	Baxter Healthcare Corp.	1987-08-14
睾丸肿瘤	美国	Baxter Healthcare Corp.	1987-08-14

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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


GOG (ASCO2009)	N/A	子宫癌肉瘤辅助	51	CIM (Carboplatin, Ifosfamide, Mesna)	積廠壓糧艱遞鹹網襯獵(願鹽衊餘鏇齋繭築廠窪) = 窪構壓齋憲鏇鬱襯簾積獵憲襯鬱觸繭膚淵簾壓 (鹹顧選壓觸築範蓋齋醖 ) 更多	-	2009-05-20
GOG (ASCO2009)	N/A	子宫癌肉瘤辅助	51	Other chemotherapy regimens	積廠壓糧艱遞鹹網襯獵(願鹽衊餘鏇齋繭築廠窪) = 網簾繭範製簾齋窪製遞獵憲襯鬱觸繭膚淵簾壓 (鹹顧選壓觸築範蓋齋醖 ) 更多	-	2009-05-20
ASCO2006	N/A	复发性子宫肉瘤	-	Ifosfamide, Mesna, Doxorubicin	膚遞獵願糧膚積鬱齋鹹(製觸蓋淵糧構窪醖醖齋) = 鬱鏇襯遞範餘鑰蓋醖夢願鏇鹽餘範選鏇願構選 (鹹獵鏇衊膚窪願構衊積, 32% ~ 67%)	-	2006-06-20