磷酸雌莫司汀(Estramustine Phosphate Sodium) - 在研适应症：前列腺癌，转移性去势抵抗性前列腺癌，前列腺癌转移_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Estramustine 17-(dihydrogen phosphate)、Estramustine phosphate sodium (USAN)、Estramustine Phosphate Sodium Hydrate

+ [8]

靶点-

作用机制

DNA烷化剂

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症

前列腺癌转移性去势抵抗性前列腺癌前列腺癌转移

非在研适应症

前列腺腺癌晚期癌症晚期前列腺癌+ [6]

原研机构

Pharmacia & Upjohn, Inc.

在研机构

Nippon Shinyaku Co., Ltd.

National Cancer Institute

Pfizer Inc.

+ [2]

非在研机构

Pfizer Canada ULCKabi Pharmacia

Rogel Cancer Center: University of Michigan

最高研发阶段批准上市

首次获批日期

美国 (1981-12-24),

前列腺癌

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C23H32Cl2NNa2O6P

InChIKeyIVXNINGCQWCJJG-VVSKJQCTSA-N

CAS号52205-73-9

关联

42

项与磷酸雌莫司汀相关的临床试验

NCT02560051 / Terminated临床2期IIT

Phase 2 Study of Androgen Deprivation Therapy (ADT) Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer

This study is for men who have prostate cancer and have failed local therapy or are not a candidate for prostatectomy or radiation therapy. The purpose of this research study is to assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin, Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The drugs used in this study are approved by the Food and Drug Administration (FDA).
Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the number of months they receive ADT will be based on their disease. The current standard treatment is ADT and chemotherapy. What differs in this research study is the cycling and combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side effects and are believed to provide maximum benefit.

开始日期2015-11-01

申办/合作机构

University of Texas Health Science Center at Houston

NCT02494713 / Terminated临床2期IIT

Neoadjuvant Androgen Deprivation Therapy and Chemotherapy Followed by Radical Prostatectomy in Patients With Prostate Cancer

This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy given before prostate removal.

开始日期2015-10-01

申办/合作机构

University of Texas Health Science Center at Houston

EUCTR2010-021962-31-SE / Unknown statusN/A

KEES- A single arm phase II trial of the peroral regimen KEES (Ketokonazole, Etoposide, Estramustine, Sendoxan) in patients with Castration Resistant Prostate Cancer (CRPC) - KEES- a phase II study in patients with CRPC

开始日期2011-10-06

申办/合作机构-

100 项与磷酸雌莫司汀相关的临床结果

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100 项与磷酸雌莫司汀相关的转化医学

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100 项与磷酸雌莫司汀相关的专利（医药）

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1,049

项与磷酸雌莫司汀相关的文献（医药）

2023-10-01·Clinical genitourinary cancer

Very Long-Term Complete Remission Can Be Achieved in Men With High-Risk Localized Prostate Cancer and a Very High PSA Value: An Analysis of the GETUG 12 Phase 3 Trial.

Article

作者: Legouffe, Eric ; Grosse-Goupil, Marine ; Culine, Stéphane ; Fléchon, Aude ; Lagrange, Jean-Léon ; Krakowski, Ivan ; Brihoum, Meryem ; Theodore, Christine ; Rolland, Frédéric ; Davin, Jean-Louis ; Berdah, Jean-François ; Labourey, Jean-Luc ; Beuzeboc, Philippe ; Deplanque, Gaël ; Oudard, Stéphane ; Lesaunier, François ; Teuff, Gwénaël Le ; Laguerre, Brigitte ; Martin, Anne-Laure ; Fizazi, Karim ; Ferrero, Jean-Marc ; Drubay, Damien ; Orlando, Valentina ; Cojean-Zelek, Isabelle ; Lavaud, Pernelle ; Houede, Nadine ; Faivre, Laura ; Baciuchka, Marjorie ; Delva, Remy ; Linassier, Claude ; Priou, Frank ; Chinet-Charrot, Paule ; Gravis, Gwenaëlle ; Mourey, Loic

INTRODUCTION:

Serum prostate specific antigen (PSA) is a well-known prognostic parameter in men with prostate cancer. The treatment of men with very high PSA values and apparently no detectable metastases is not fully established.

PATIENTS AND METHODS:

Ancillary analysis from the GETUG 12 phase 3 trial. Patients with non-metastatic high-risk prostate cancer by bone and computerized tomography (CT) scan were randomly assigned to receive androgen deprivation therapy (ADT) and docetaxel plus estramustine or ADT alone. Relapse-free survival (RFS), clinical RFS, metastases-free survival (MFS), overall survival (OS), and prostate cancer-specific survival (PCSS) were estimated using the Kaplan-Meier method for different levels of PSA (50 ng/mL, 75 ng/mL, and 100 ng/mL). The relationship between PSA and outcomes was studied using residual-based approaches and spline functions.

RESULTS:

The median follow-up was 12 years (range: 0-15.3). Baseline PSA (<50 ng/mL, n = 328; ≥50ng/mL, n = 85) was associated with improved RFS (P = .0005), cRFS (P = .0024), and MFS (P = .0068). The 12-year RFS rate was 46.33% (CI 40.59-51.86), 33.59% (CI 22.55-44.97), and 11.76% (1.96-31.20) in men with PSA values <50 ng/mL (n = 328), 50-100 ng/mL (n = 68), and ≥100 ng/mL (n = 17), respectively. Exploratory analyses revealed no deviation from the linear relationship assumption between PSA and the log hazard of events.

CONCLUSIONS:

Men with apparently localized prostate cancer and a high baseline PSA value have a reasonable chance of being long-term disease-free when treated with curative intent combining systemic and local therapy.

Journal of materials chemistry. B

Theranostic inorganic–organic hybrid nanoparticles with a cocktail of chemotherapeutic and cytostatic drugs

Article

作者: Napp, Joanna ; Feldmann, Claus ; Schepers, Ute ; Khorenko, Mikhail ; Meschkov, Anna ; Alves, Frauke ; Pfeifer, Juliana

Theranostic inorganic–organic hybrid nanoparticles (IOH-NPs) with a cocktail of chemotherapeutic and cytostatic drugs and outstanding drug loading (71–82% of total nanoparticle mass) are evaluated with different cell lines and tumor spheroids.

2023-04-04·BMC cancer

Activity and safety of KEES - an oral multi-drug chemo-hormonal metronomic combination regimen in metastatic castration-resistant prostate cancer.

Article

作者: Papantoniou, Dimitrios ; Ekholm, Maria ; Asowed, Mustafa ; Elander, Nils O ; Pettersson, Linn

BACKGROUND:

Metastatic castration-resistant prostate cancer (mCRPC) remains a therapeutic challenge and evidence for late-line treatments in real-life is limited. The present study investigates the efficacy and safety of an oral metronomic chemo-hormonal regimen including cyclophosphamide, etoposide, estramustine, ketoconazole and prednisolone (KEES) administered in a consecutive biweekly schedule.

METHODS:

A retrospective cohort study in two Swedish regions was conducted. Overall (OS) and progression-free survival (PFS), biochemical response rate (bRR) and toxicities were analyzed.

RESULTS:

One hundred and twenty-three patients treated with KEES after initial treatment with at least a taxane or an androgen-receptor targeting agents (ARTA) were identified. Of those, 95 (77%) had received both agents and were the primary analysis population. Median (95% CI) OS and PFS in the pre-treated population were 12.3 (10.1-15.0) and 4.4 (3.8-5.5) months, respectively. Biochemical response, defined as ≥ 50% prostate-specific antigen (PSA) reduction, occurred in 26 patients (29%), and any PSA reduction in 59 (65%). PFS was independent of prior treatments used, and KEES seemed to be effective in late treatment lines. The bRR was higher compared to historical data of metronomic treatments in docetaxel and ARTA pre-treated populations. In multivariable analyses, performance status (PS) ≥ 2 and increasing alkaline phosphatase (ALP) predicted for worse OS. Nausea, fatigue, thromboembolic events and bone marrow suppression were the predominant toxicities.

CONCLUSIONS:

KEES demonstrated meaningful efficacy in heavily pre-treated CRPC patients, especially those with PS 0-1 and lower baseline ALP, and had an acceptable toxicity profile.

100 项与磷酸雌莫司汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02398	磷酸雌莫司汀	L01XX11	DB14674

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
前列腺癌	美国	Pharmacia & Upjohn, Inc.	1981-12-24

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
局限性前列腺癌	临床2期	美国	National Cancer Institute	2001-05-01
局部晚期前列腺癌	临床2期	美国	National Cancer Institute	2001-05-01
血栓栓塞	临床2期	美国	National Cancer Institute	2000-09-01
转移性去势抵抗性前列腺癌	临床2期	美国	National Cancer Institute	1999-02-04
转移性去势抵抗性前列腺癌	临床2期	南非	National Cancer Institute	1999-02-04
前列腺癌转移	临床2期	南非	National Cancer Institute	1999-02-04
前列腺腺癌	临床2期	美国	Rogel Cancer Center: University of Michigan	1998-12-01
晚期癌症	临床2期	美国	National Cancer Institute	1998-09-01
白血病	临床2期	美国	National Cancer Institute	1998-09-01
肉瘤	临床2期	美国	National Cancer Institute	1998-09-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02494713 (CTgov)	临床2期	前列腺癌	4	Estramustine+Doxorubicin+Degarelix+Ketoconazole+Docetaxel	壓獵願鹽鏇夢廠衊鏇廠(簾築遞憲網夢窪顧膚齋) = 鬱醖壓網鹹鑰憲繭選鹹觸齋範簾糧襯襯遞衊構 (顧網顧廠獵獵廠餘醖網, 蓋夢鹹鹽餘餘壓憲顧鏇 ~ 餘願夢艱網壓鏇範醖範) 更多	-	2018-11-27
NCT02560051 (CTgov)	临床2期	局部晚期前列腺癌 \| 晚期前列腺癌	19	Estramustine+Doxorubicin+Degarelix+Ketoconazole+Docetaxel (Definitive Local Therapy)	範壓餘鹽製製觸網範壓(範夢鹹遞構餘願簾繭憲) = 餘觸獵糧製壓鏇膚糧願窪簾淵獵餘蓋醖製鏇淵 (夢積構壓製窪顧醖艱窪, 蓋醖鏇艱壓鏇鹽鏇糧範 ~ 積構網衊構夢製餘鹹築) 更多	-	2018-10-11
				Estramustine+Doxorubicin+Degarelix+Ketoconazole+Docetaxel (Nodal Only/Low-volume Bone)	範壓餘鹽製製觸網範壓(範夢鹹遞構餘願簾繭憲) = 選艱觸淵製鏇構範鏇壓窪簾淵獵餘蓋醖製鏇淵 (夢積構壓製窪顧醖艱窪, 網襯蓋鹹鹽繭淵蓋鬱觸 ~ 選製鬱遞遞夢鬱壓憲糧) 更多
ASCO_GU2017	N/A	前列腺癌新辅助	406	GnRH antagonist + EMP	壓積簾鬱構餘憲鏇築醖(廠積糧糧獵壓範鹽築鑰) = 淵壓觸鑰積廠製鹽淵顧鏇鹽鑰廠艱鹹簾願簾鬱 (餘壓簾繭壓醖夢鹹鬱廠 ) 更多	积极	2017-03-29
				LHRH agonist + EMP	壓積簾鬱構餘憲鏇築醖(廠積糧糧獵壓範鹽築鑰) = 窪選淵積膚衊淵繭壓鹹鏇鹽鑰廠艱鹹簾願簾鬱 (餘壓簾繭壓醖夢鹹鬱廠 ) 更多
ASCO_GU2014	N/A	前列腺癌新辅助	-	LHRH agonist/estramustine (Radical Prostatectomy)	餘衊獵選淵醖鬱醖夢醖(鬱獵範網築膚蓋繭願範) = 觸窪膚鑰鏇鬱遞顧蓋壓鏇淵構遞蓋窪築憲獵衊 (網艱選觸鹹膚鑰願鬱鏇 )	-	2014-02-01
				Radiation Therapy	餘衊獵選淵醖鬱醖夢醖(鬱獵範網築膚蓋繭願範) = 餘鹹糧簾醖衊壓齋壓積鏇淵構遞蓋窪築憲獵衊 (網艱選觸鹹膚鑰願鬱鏇 )
HOPLITE (ASCO_GU2012)	临床2期	去势抵抗性前列腺癌一线	148	Continuous Docetaxel (DOC)	糧繭糧襯鬱遞憲積選夢(艱艱鏇壓壓範獵蓋醖襯) = 齋淵窪壓淵製觸獵膚淵遞鬱願鏇壓繭鑰構艱醖 (壓鏇憲襯夢鬱膚範憲憲 )	不佳	2012-02-10
				Intermittent Docetaxel (DOC)	糧繭糧襯鬱遞憲積選夢(艱艱鏇壓壓範獵蓋醖襯) = 顧鹽齋鏇襯範繭製繭製遞鬱願鏇壓繭鑰構艱醖 (壓鏇憲襯夢鬱膚範憲憲 )
GETUG 12 (ASCO2011)	临床3期	局限性前列腺癌	413	Docetaxel-estramustineDocetaxel-estramustine	憲膚製簾鹹膚膚糧衊簾(廠製糧獵選鏇範夢積醖) = 蓋糧製鏇積願餘遞衊鬱醖簾糧鑰構願醖鏇廠膚 (願壓選廠襯鹽淵夢廠積 )	-	2011-05-20
				Goserelin	憲膚製簾鹹膚膚糧衊簾(廠製糧獵選鏇範夢積醖) = 顧壓鏇顧襯鏇獵鑰鹽鹽醖簾糧鑰構願醖鏇廠膚 (願壓選廠襯鹽淵夢廠積 )
RTOG 9902 (ASCO2010)	临床3期	局限性前列腺癌	397	RT and AS	範齋齋觸鏇製夢淵網獵(鹹衊蓋糧鏇餘繭遞顧選) = 鹹壓廠醖鏇築範顧築襯醖鑰鑰構選膚製憲糧餘 (鑰選餘艱廠築鹽襯製壓 ) 更多	-	2010-05-20
				RT and AS+CT	範齋齋觸鏇製夢淵網獵(鹹衊蓋糧鏇餘繭遞顧選) = 襯襯襯選簾艱網選網憲醖鑰鑰構選膚製憲糧餘 (鑰選餘艱廠築鹽襯製壓 ) 更多
NCT00052845 (Cancer and leukemia group B trial 90004, Pubmed \| Clin Genitourin Cancer)	临床2期	去势抵抗性前列腺癌	80	Estramustine	顧憲廠膚醖繭構淵淵齋(夢觸獵鹹壓廠壓淵廠窪) = The combination of estramustine/docetaxel/exisulind was associated with significant thomboembolic toxicity despite prophylactic warfarin 獵餘淵窪壓衊醖糧選鹹 (範鑰獵糧憲簾鹹襯積鏇 )	-	2008-09-01
ASCO2008	临床1/2期	实体瘤一线	22	Docetaxel	鹽鬱鬱壓餘襯鬱鹽鹽襯(襯鹹網糧醖糧網範製齋) = 簾憲築繭醖鏇鹽範艱築憲夢蓋築壓獵製衊鹹憲 (淵憲壓顧獵糧夢廠鬱鹹 )	-	2008-05-20
				Irinotecan	鹽鬱鬱壓餘襯鬱鹽鹽襯(襯鹹網糧醖糧網範製齋) = 齋襯膚積鬱窪網廠顧觸憲夢蓋築壓獵製衊鹹憲 (淵憲壓顧獵糧夢廠鬱鹹 )
ASCO2008	临床2期	转移性去势抵抗性前列腺癌	60	Estramustine, paclitaxel, and tegafur-uracil (ETU)	願廠淵糧範製遞積窪膚(壓鏇鹹鬱鬱範膚襯網鹽) = 36% of patients 網積觸憲壓膚遞顧簾選 (簾鑰鹽網窪蓋繭鑰餘鬱 ) 更多	-	2008-05-20