多西他赛脂质体(Liposomal docetaxel) - 药物靶点：Tubulin_在研适应症：乳腺癌，食管癌，非小细胞肺癌_专利_临床

A phase 1 study to determine safety, tolerability, pharmacokinetics, dose proportionality and MTD of Liposomal Docetaxel injection in subjects with advanced solid tumors. - NA

开始日期2021-02-25

申办/合作机构

Shilpa Medicare Ltd.

CTR20132581 / Recruiting临床1期IIT

多西他赛脂质微球注射液人体安全性、耐受性、药代动力学研究I 期临床试验

观察多西他赛脂质微球注射液在人体中的安全性，确定其MTD及剂量限制性毒性DLT，为II期临床研究推荐安全剂量。评价多西他赛脂质微球在人体的药代动力学特征，并与普通注射剂临床常规剂量进行对比研究，以观察新剂型与原剂型所引起的药代、初步安全性的变化。初步观察其的临床疗效，并与普通注射剂临床常规剂量进行比较。

开始日期2012-09-10

申办/合作机构

沈阳药科大学

NCT01041235 / Completed临床1期

A Phase I, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered ATI-1123, a Liposomal Docetaxel Formulation, on an Every 3 Week Schedule, in Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety profile, including the maximum tolerated dose (MTD), of ATI-1123 a liposomal formulation of docetaxel, in the treatment of cancer patients with advanced solid tumors.

开始日期2009-12-01

申办/合作机构

Azaya Therapeutics, Inc.

100 项与多西他赛脂质体相关的临床结果

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100 项与多西他赛脂质体相关的转化医学

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100 项与多西他赛脂质体相关的专利（医药）

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11

项与多西他赛脂质体相关的文献（医药）

2020-12-01·Cancer Communications1区 · 医学

Phase II clinical trial using camrelizumab combined with apatinib and chemotherapy as the first‐line treatment of advanced esophageal squamous cell carcinoma

1区 · 医学

ArticleOA

作者: Wang, Xingyuan ; Huang, Jing ; Mu, Lan ; Wang, Xi ; Qi, Ling ; Liu, Yun ; Zhang, Bo ; Bai, Lidan ; Xu, Jianping

AbstractBackgroundEffective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma (ESCC). The incorporation of an immune checkpoint inhibitor and a molecular anti‐angiogenic agent into the commonly adopted chemotherapy may produce synergistic effects. Therefore, we aimed to investigate the efficacy and safety of camrelizumab plus apatinib combined with chemotherapy as the first‐line treatment of advanced ESCC.MethodsIn this single‐arm prospective phase II trial, patients with unresectable locally advanced or recurrent/metastatic ESCC received camrelizumab 200 mg, liposomal paclitaxel 150 mg/m2, and nedaplatin 50 mg/m2 on day 1, and apatinib 250 mg on days 1‐14. The treatments were repeated every 14 days for up to 9 cycles, followed by maintenance therapy with camrelizumab and apatinib. The primary endpoint was objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (version 1.1). Secondary endpoints included disease control rate (DCR), progression‐free survival (PFS), overall survival (OS), and safety.ResultsWe enrolled 30 patients between August 7, 2018 and February 23, 2019. The median follow‐up was 24.98 months (95% confidence interval [CI]: 23.05‐26.16 months). The centrally assessed ORR was 80.0% (95% CI: 61.4%‐92.3%), with a median duration of response of 9.77 months (range: 1.54 to 24.82+ months). The DCR reached 96.7% (95% CI: 82.8%‐99.9%). The median PFS was 6.85 months (95% CI: 4.46‐14.20 months), and the median OS was 19.43 months (95% CI: 9.93 months – not reached). The most common grade 3‐4 treatment‐related adverse events (AEs) were leukopenia (83.3%), neutropenia (60.0%), and increased aspartate aminotransferase level (26.7%). Treatment‐related serious AEs included febrile neutropenia, leukopenia, and anorexia in one patient (3.3%), and single cases of increased blood bilirubin level (3.3%) and toxic epidermal necrolysis (3.3%). No treatment‐related deaths occurred.ConclusionsCamrelizumab plus apatinib combined with liposomal paclitaxel and nedaplatin as first‐line treatment demonstrated feasible anti‐tumor activity and manageable safety in patients with advanced ESCC. Randomized trials to evaluate this new combination strategy are warranted.Trial registrationThis trial was registered on July 27, 2018, at ClinicalTrials.gov (identifier: NCT03603756).

2016-12-01·Journal of Controlled Release

Liposomal prednisolone inhibits tumor growth in a spontaneous mouse mammary carcinoma model

Article

作者: Maria Gomes Coimbra ; G Storm ; Anil K. Deshantri ; Sylvia A. Kuijpers ; Marcel H A M Fens ; Sander A A Kooijmans ; Astrid Hoeppener ; Raymond M. Schiffelers

Cancers are abundantly infiltrated by inflammatory cells that are modulated by tumor cells to secrete mediators fostering tumor cell survival and proliferation. Therefore, agents that interfere with inflammatory signaling molecules or specific immune cell populations have been investigated as anticancer drugs. Corticosteroids are highly potent anti-inflammatory drugs, whose activity is intensified when targeted by nanocarrier systems. Liposome-targeted corticosteroids have been shown to inhibit tumor growth in different syngeneic murine tumor models as well as human xenograft mouse models, which is attributed to a switch in the tumor microenvironment from a pro-inflammatory to an anti-inflammatory state. Despite the recognized value of implantation tumor models in preclinical research, the "acute" inflammation induced by inoculation of tumor cells together with the exponential tumor growth in a relatively short period of time does not resemble slow progressive human disease that develops in situ. Therefore, in this study, the antitumor effect of liposomal corticosteroids was investigated in a clinically more relevant setting of transgenic mice developing spontaneous breast carcinomas. Here we show that liposomal prednisolone phosphate inhibits the growth of spontaneous breast carcinoma. Interestingly, the liposomal prednisolone was significantly more active than free drug. At 72h after injection of the liposomal formulation, 3μg prednisolone per gram of tumor tissue was recovered whereas no drug could be recovered after injection of the free agent. This indicates that, despite etiological and morphological differences between implanted and spontaneous tumor models, EPR-mediated accumulation of drug occurs to similar extent in this spontaneous mammary carcinoma model as in the syngeneic tumor models. Finally, we analyzed miRNA profiles in the MMTV/neu model and showed that the top 10 of miRNAs in the MMTV/neu tumor consisted of miRNAs with a known involvement in breast carcinoma proliferation and metastasis. The only exception was the appearance of miR-146b, a known inflammation-regulating miRNA species, after liposomal prednisolone treatment.

2014-09-01·Journal of Controlled Release1区 · 医学

Liposomal corticosteroids for the treatment of inflammatory disorders and cancer

1区 · 医学

Review

作者: Lammers, Twan ; Metselaar, Josbert M ; Crielaard, Bart J ; Ozbakir, Burcin ; Storm, Gert

Glucocorticoids (GC) are known for their potent immunosuppressive and anti-inflammatory properties. As a consequence, they have been extensively used for the treatment of many different diseases. Prolonged and/or high-dose GC therapy, however, generally comes with severe side effects, resulting not only from their very diverse mechanism(s) of action, but also from their relatively poor biodistribution. Drug delivery systems, and in particular liposomes, have been extensively used to enhance the biodistribution and the target site accumulation of GC, and to thereby improve the balance between their efficacy and their toxicity. Many different types of liposomes have been employed, and both local and systemic treatments have been evaluated. We here summarize the progress made in the use of liposomal GC formulations for the treatment of asthma, rheumatoid arthritis, multiple sclerosis and cancer, and we show that the targeted delivery of GC to pathological sites holds significant clinical potential.

100 项与多西他赛脂质体相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床2期	美国	Azaya Therapeutics, Inc.	2009-12-01
乳腺癌	临床2期	美国	Azaya Therapeutics, Inc.	2009-12-01
卵巢癌	临床2期	美国	Azaya Therapeutics, Inc.	2009-12-01
胰腺癌	临床2期	美国	Azaya Therapeutics, Inc.	2009-12-01
食管癌	临床1期	中国	沈阳药科大学	2012-09-10
非小细胞肺癌	临床1期	中国	沈阳药科大学	2012-09-10
前列腺癌	临床1期	中国	沈阳药科大学	2012-09-10
软组织肿瘤	临床1期	中国	沈阳药科大学	2012-09-10
胃癌	临床1期	中国	沈阳药科大学	2012-09-10
肿瘤	药物发现	中国	东曜药业有限公司	-

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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


CSCO2020	N/A	鼻咽癌	801	Docetaxel and cisplatin	(衊觸範膚憲淵選蓋膚選) = TPF can produce more mucosal and nausea/vomiting adverse reactions than TP 衊壓簾鬱艱壓遞衊製襯 (網憲齋醖廠積壓壓選築 )	积极	2020-09-19
				Docetaxel, cisplatin, and fluorouracil
OAK Trial (WCLC2018)	N/A	晚期非小细胞肺癌	425	Atezolizumab + Metformin	(蓋膚鹽觸簾繭顧窪蓋鏇) = 範繭齋網鹽艱鑰鹽鹹鏇願築壓蓋淵簾夢網製夢 (遞築簾艱夢鏇夢鑰築築 ) 更多	-	2018-09-24
				Atezolizumab without Metformin	(蓋膚鹽觸簾繭顧窪蓋鏇) = 製鹽窪構齋淵鹽鏇艱蓋願築壓蓋淵簾夢網製夢 (遞築簾艱夢鏇夢鑰築築 ) 更多
PD15-10 (AUA2015)	N/A	肾细胞癌	-	Sorafenib-encapsulated liposomes	鏇艱衊範觸網衊遞顧遞(網鑰選選艱淵醖顧醖蓋) = 簾鹽願鹽觸鬱膚願遞顧餘繭窪醖鹹鏇鹹憲衊鏇 (鹽蓋壓鑰繭糧積夢獵鬱 ) 更多	-	2015-04-01
				Sorafenib alone	繭積齋網鬱鑰獵衊壓廠(鹹糧窪遞蓋鹽鏇鑰艱艱) = 膚蓋鏇範憲獵簾顧觸壓壓簾鹹獵簾夢遞築鏇夢 (壓鑰餘積夢繭憲壓蓋餘 )
AHNS2014	N/A	-	30	Induction docetaxel, cisplatin, and 5-fluorouracil chemotherapy	(鹽窪蓋網衊鏇鏇窪網鬱) = 製鹹積糧夢鑰廠淵淵積夢範構壓夢膚製簾鹹鬱 (衊鑰淵淵範鏇範顧憲築 ) 更多	-	2014-07-29