Delving into the Latest Updates on Liposomal docetaxel with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

Tubulin

Mechanism

Tubulin inhibitors, Cells inhibitors, Mitosis inhibitors

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [3]

Active Indication

Breast CancerEsophageal CarcinomaNon-Small Cell Lung Cancer+ [5]

Inactive Indication

Advanced Malignant Solid Neoplasm

Originator Organization

Tot Biopharm Co. Ltd.

Active Organization

Shenyang Pharmaceutical University

Inactive Organization

Azaya Therapeutics, Inc.

Tot Biopharm Co. Ltd.

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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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。

[Translation]

Observe the safety of docetaxel lipid microsphere injection in humans, determine its MTD and dose-limiting toxicity DLT, and recommend a safe dose for Phase II clinical studies. Evaluate the pharmacokinetic characteristics of docetaxel lipid microspheres in humans, and conduct a comparative study with the conventional clinical dose of ordinary injections to observe the changes in pharmacokinetic and preliminary safety caused by the new dosage form and the original dosage form. Preliminarily observe its clinical efficacy and compare it with the conventional clinical dose of ordinary injections.

Start Date10 Sep 2012

Sponsor / Collaborator

Shenyang Pharmaceutical University

NCT01041235 / CompletedPhase 1

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.

Start Date01 Dec 2009

Sponsor / Collaborator

Azaya Therapeutics, Inc.

100 Clinical Results associated with Liposomal docetaxel

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100 Translational Medicine associated with Liposomal docetaxel

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100 Patents (Medical) associated with Liposomal docetaxel

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11

Literatures (Medical) associated with Liposomal docetaxel

01 Dec 2020·Cancer CommunicationsQ1 · MEDICINE

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

Q1 · MEDICINE

ArticleOA

Author: 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).

01 Dec 2016·Journal of Controlled Release

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

Article

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

01 Sep 2014·Journal of Controlled ReleaseQ1 · MEDICINE

Liposomal corticosteroids for the treatment of inflammatory disorders and cancer

Q1 · MEDICINE

Review

Author: 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 Deals associated with Liposomal docetaxel

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Esophageal Carcinoma	Phase 1	CN	Shenyang Pharmaceutical University	10 Sep 2012
Non-Small Cell Lung Cancer	Phase 1	CN	Shenyang Pharmaceutical University	10 Sep 2012
Prostatic Cancer	Phase 1	CN	Shenyang Pharmaceutical University	10 Sep 2012
Soft Tissue Neoplasms	Phase 1	CN	Shenyang Pharmaceutical University	10 Sep 2012
Stomach Cancer	Phase 1	CN	Shenyang Pharmaceutical University	10 Sep 2012
Advanced Malignant Solid Neoplasm	Preclinical	US	Azaya Therapeutics, Inc.	01 Dec 2009
Breast Cancer	Preclinical	US	Azaya Therapeutics, Inc.	01 Dec 2009
Ovarian Cancer	Preclinical	US	Azaya Therapeutics, Inc.	01 Dec 2009
Pancreatic Cancer	Preclinical	US	Azaya Therapeutics, Inc.	01 Dec 2009
Neoplasms	Discovery	CN	Tot Biopharm Co. Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CSCO2020	Not Applicable	Nasopharyngeal Carcinoma	801	Docetaxel and cisplatin	(odqzroynhg) = TPF can produce more mucosal and nausea/vomiting adverse reactions than TP lthrwunesl (harxxlnwhb )	Positive	19 Sep 2020
				Docetaxel, cisplatin, and fluorouracil
OAK Trial (WCLC2018)	Not Applicable	Advanced Lung Non-Small Cell Carcinoma	425	Atezolizumab + Metformin	(bpesvkenln) = sboicljsvz gksgilhpho (lhpvwhuspd ) View more	-	24 Sep 2018
				Atezolizumab without Metformin	(bpesvkenln) = aegbofsijl gksgilhpho (lhpvwhuspd ) View more
PD15-10 (AUA2015)	Not Applicable	Renal Cell Carcinoma	-	Sorafenib-encapsulated liposomes	iuzxeovbnl(rkqscsbrej) = jjrjnfzfty qhrbikqwux (axdutbvnxx ) View more	-	01 Apr 2015
				Sorafenib alone	drslavhkqz(mvfgqgupzo) = ufydpqsqsd wlwpwehuuz (kwepsrpjjj )
AHNS2014	Not Applicable	-	30	Induction docetaxel, cisplatin, and 5-fluorouracil chemotherapy	(kjthfqvozw) = hodqwjyvtn rvfdbethos (lyamzentwv ) View more	-	29 Jul 2014