更新于：2024-12-20
Anlotinib Dihydrochloride
盐酸安罗替尼
更新于：2024-12-20
概要
基本信息
药物类型 小分子化药 |
别名 ALTN、Anlotinib、Anlotinib Hydrochloride + [6] |
作用机制 FGFRs拮抗剂(成纤维细胞生长因子受体家族拮抗剂)、PDGFR拮抗剂(血小板衍生生长因子受体拮抗剂)、Tyrosine kinase inhibitors |
非在研适应症 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2018-05-08), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、附条件批准 (中国)、特殊审批 (中国)、孤儿药 (美国) |
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结构
分子式C23H23ClFN3O3 |
InChIKeyGTAUHBAHFJIAQT-UHFFFAOYSA-N |
CAS号1360460-82-7 |
关联
634
项与 盐酸安罗替尼 相关的临床试验The efficacy and safety of ifosfamide/etoposide ± anlotinib in the treatment of advanced undifferentiated small round cell sarcoma patients with progression or recurrence after anthracycline-based chemotherapy: a non-comparative randomised trial
ARTEMIS-103: a Phase 1b, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination with Other Anti-cancer Agents in Patients with Bone and Soft Tissue Sarcoma.
A New Option for Post-CDK4/6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6is.
100 项与 盐酸安罗替尼 相关的临床结果
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100 项与 盐酸安罗替尼 相关的转化医学
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100 项与 盐酸安罗替尼 相关的专利（医药）
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908
项与 盐酸安罗替尼 相关的文献（医药）2025-01-01CLINICA CHIMICA ACTA
LC-MS/MS method for quantification of 23 TKIs in Plasma: Assessing the relationship between anlotinib trough concentration and toxicities
Article
作者: Bu, Chen ; Liang, Zhengyan ; Chen, Wansheng ; Wang, Zhipeng ; Cui, Lili ; Nian, Jiayao ; Gao, Shouhong ; Zhao, Yingkui ; Tang, Mao ; Song, Xinhua ; Tao, Xia ; Jiang, Liansheng ; Ye, Liya
OBJECTIVES:
To develop a simple, rapid, and sensitive LC-MS/MS method for quantifying 23 tyrosine kinase inhibitors (TKIs) in plasma samples, and evaluate the relationship between the trough concentration of anlotinib(ANL) and its toxicities.
METHODS:
The method was developed in Agilent 1290-6460 UHPLC-MS/MS system. This study prospectively enrolled 55 cancer patients undergoing ANL treatment. Plasma samples were collected at steady-state trough concentration and subsequently analyzed using the method. Patients were recorded for the occurrence of toxicities. Statistical analysis was performed to assess the association of the toxicities with ANL exposure level and patients' characteristics.
RESULTS:
The LC-MS/MS method was developed and validated for all items required by pharmacopoeia. The results revealed a positive association between the trough concentration of ANL and the incidence of toxicities. The exposure level 17.655 ng/mL (AUC 0.82, p = 0.010) was identified as a predictive threshold value for grade ≥ 3 overall toxicities. In addition, lower platelet count (PLT count < 179 × 109 g/L) was significantly associated with higher occurrence of grade ≥ 3 toxicities (AUC 0.75, p = 0.049). A logistic model incorporating these two factors demonstrated improved diagnostic capacity for predicting ≥ 3 overall toxicities (AUC = 0.90, p = 0.001).
CONCLUSIONS:
This study successfully developed and validated a simple, rapid, and sensitive LC-MS/MS method for quantifying 23 TKIs in plasma samples. Besides, this study found that both Ctrough of ANL and PLT count as independent predictors for ANL-induced ≥ 3 overall toxicities. Moreover, a logistic model including these two factors presents better prediction capacity for ≥ 3 overall toxicities.
2025-01-01ANTI-CANCER DRUGS
Combination of anlotinib and sintilimab for the treatment of recurrent or metastatic head and neck squamous cell carcinoma: a single-arm prospective study
Article
作者: Wang, Tianxiao ; Wang, Jiaxin ; Song, Yuntao ; Zhang, Bin ; Xu, Guohui ; Zhang, Yabing
To investigate whether blocking both programmed cell death protein and vascular endothelial growth factor receptor could offer superior anticancer activity in these patients without compromising safety. In this study, patients were administered oral anlotinib (12 mg/day) on days 1–14 and intravenous sintilimab (200 mg) on day 1 of a 3-weekly cycle. The primary endpoints included the objective response rate and disease control rate. The secondary endpoints included overall survival (OS) and safety. Ten eligible patients were enrolled between June 2019 and May 2022, and eight patients underwent radiographic assessments. The results showed an objective response rate of 50% (partial and complete response in four and zero patients, respectively) and a disease control rate of 100%; four patients demonstrated stable disease for at least 8 weeks. The median OS was 4.37 (in our study, the score was 7), and the OS rate at 12 months was 37.5%. The Kaplan–Meier survival curve showed that the group with high blood glucose levels had a significantly shorter duration of survival than those with normal blood glucose levels. Adverse events of grade 3 and higher occurred in 50% of patients, and the most common severe adverse events included tumor pain (50%), hypertension (37.5%), tumor hemorrhage (25%), and decreased appetite (25%). The combination of anlotinib and sintilimab showed promising efficacy in controlling tumor size. However, the disappointing OS rate suggests that anti-vascular endothelial growth factor receptor agents should be used cautiously after radical radiation therapy. The combination used in this study demonstrated a toxicity profile comparable to that of other agents used in this setting. These findings warrant further investigation into the potential clinical utility of this combination.
2024-12-31Future Science OA
Cytokine release syndrome caused by immune checkpoint inhibitors: a case report and literature review
Article
作者: You, Yang ; Zhang, Xiuping ; Zhang, Pengfei ; Wang, Yan ; Shen, Feng
Immune checkpoint inhibitors (ICIs) have gained widespread application in the treatment of malignant tumors. Cytokine release syndrome (CRS) is a systemic inflammatory response triggered by various factors, including infections and immunotherapy. We present a case of CRS occurring in a gastric cancer patient after receiving combination therapy of tislelizumab, anlotinib and combination of capecitabine and oxaliplatin. Nineteen days after the third dose of tislelizumab, the patient experienced sudden unconsciousness, frothing at the mouth, convulsions and other clinical manifestations resembling epileptiform seizures. Elevated inflammatory markers, cytokine levels and ferritin were markedly increased. Given the absence of definite clinical evidence for metastasis and infection, the diagnosis of CRS was considered. Subsequent management with glucocorticoids and intravenous immunoglobulin resulted in the patient's improvement. However, antitumor therapy was halted, ultimately leading to death. The administration of ICIs can incite CRS, a severe, rapidly progressing condition with a poor prognosis, demanding clinical attention. Cytokines play a dual role in the pathophysiology of immune-related adverse events by mediating self-tolerance attenuation and enhancing the activation of cytotoxic T cells in the antitumor process of ICIs. The therapy of glucocorticoids combined with cytokine inhibitors may become an effective remedy.
100 项与 盐酸安罗替尼 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 子宫内膜癌 | 中国 | 2024-11-22 | |
| 广泛期小细胞肺癌 | 中国 | 2024-05-08 | |
| 分化型甲状腺癌 | 中国 | 2022-04-08 | |
| 甲状腺髓样癌 | 中国 | 2021-01-30 | |
| 小细胞肺癌 | 中国 | 2019-09-01 | |
| 软组织肉瘤 | 中国 | 2019-07-01 | |
| 非小细胞肺癌 | 中国 | 2018-05-08 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肝细胞癌 | 申请上市 | 中国 | 2024-11-21 | |
| 转移性肾细胞癌 | 申请上市 | 中国 | 2024-08-01 | |
| 不可切除的肾细胞癌 | 申请上市 | 中国 | 2024-08-01 | |
| 原发性腹膜癌 | 临床3期 | 美国 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 美国 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 中国 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 中国 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 意大利 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 意大利 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 西班牙 | 2022-04-06 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 75 | Aumolertinib plus Anlotinib | 簾廠選餘艱觸襯積構遞(積觸齋鏇蓋蓋鹹鹹鑰壓) = 夢築夢鑰鏇網鬱蓋鬱選 鬱齋膚鏇蓋鹹鬱遞膚繭 (繭願願願餘衊範構艱衊, 9.2 ~ 22.6) 更多 | 积极 | 2024-12-07 | ||
Aumolertinib plus Anlotinib (intracranially) | 簾廠選餘艱觸襯積構遞(積觸齋鏇蓋蓋鹹鹹鑰壓) = 選繭廠鏇糧廠窪製鹹獵 鬱齋膚鏇蓋鹹鬱遞膚繭 (繭願願願餘衊範構艱衊 ) 更多 | ||||||
临床2期 | 26 | 顧襯膚衊鏇鬱鹽夢蓋網(鬱襯夢獵築餘鹹簾餘蓋) = 構糧糧衊壓糧範鏇餘醖 窪艱膚醖醖鏇網淵衊顧 (繭積蓋願憲積觸憲淵觸, 80.4 ~ 99.9) 更多 | 积极 | 2024-12-07 | |||
(Intracranial) | 顧襯膚衊鏇鬱鹽夢蓋網(鬱襯夢獵築餘鹹簾餘蓋) = 艱構艱鏇鬱窪鹹窪網鹽 窪艱膚醖醖鏇網淵衊顧 (繭積蓋願憲積觸憲淵觸, 50.1 ~ 93.2) 更多 | ||||||
ESMO_ASIA2024 人工标引  | N/A | 1 | 獵齋膚鹹網鏇積遞積淵(選觸積鹹糧醖衊齋願窪) = 觸願淵選鹽醖鑰廠壓壓 選選衊廠願鹽鹽願鏇襯 (鏇範願廠顧觸積選艱齋 ) | 积极 | 2024-12-07 | ||
临床2期 | 子宫内膜癌 non-MSI-H/dMMR | 85 | (stage 2 of cohort 1) | 築壓簾壓襯鑰遞壓壓鏇(壓窪艱選糧壓獵繭膚憲) = 遞築膚選鬱範糧願淵齋 窪選願壓夢廠壓範鹽淵 (遞願鹹鏇觸衊鹹遞蓋窪 ) 更多 | 积极 | 2024-11-05 | |
临床2期 | 膀胱癌 PD-L1 | 6 | 淵顧顧願齋築網鑰觸繭(艱構衊淵膚築窪構鹹憲) = 網積憲鹹獵糧淵製鹽醖 鏇糧鹽選遞衊壓簾鹽鹽 (鑰夢壓壓遞範艱鑰構夢 ) | 积极 | 2024-10-30 | ||
廠壓鏇簾遞鏇鹹糧觸顧(製艱艱鬱獵鏇願蓋繭築) = 鏇襯觸構網憲餘構窪蓋 鏇繭遞衊鬱齋遞醖構窪 (鑰製顧獵廠繭衊醖簾簾 ) | |||||||
临床2期 | 153 | STUPP regimen + Anlotinib | 餘選廠遞願顧糧鏇顧網(構觸壓鹹衊襯鬱齋構膚) = 網鹽醖壓鏇餘製構餘夢 築窪觸鑰鹽憲顧膚艱選 (願顧餘願簾顧鹽醖糧醖, 64.82% ~ 79.11) 更多 | 积极 | 2024-10-17 | ||
STUPP regimen + Placebo | 觸觸艱艱齋簾窪簾網選(鏇艱觸網願範積鹽獵膚) = 願衊蓋鑰製顧壓網鬱憲 鑰簾獵鏇構顧襯顧衊鹽 (壓壓憲網範繭膚願遞築 ) | ||||||
临床2期 | 19 | Anlotinib + Radiotherapy | 鏇醖觸夢觸鑰鏇構鹽窪(艱鏇鑰憲壓願觸顧鏇壓) = 餘遞觸襯壓蓋鑰積製鏇 顧憲淵襯網窪願蓋廠繭 (壓願壓齋簾襯顧鏇築淵 ) 更多 | 积极 | 2024-10-17 | ||
临床2期 | 小细胞肺癌 二线 | 21 | 構顧鑰範製網糧製淵選(鑰網夢鹽顧淵築醖繭網) = 築襯壓築製糧夢夢鹽鏇 廠醖餘範衊構繭鏇獵鏇 (蓋觸鹽繭淵積簾繭衊繭, 17.7 ~ 66.6) 更多 | 积极 | 2024-10-01 | ||
NEWS 人工标引 | N/A | 17 | 蓋築願鹽襯齋淵醖壓醖(襯願鏇觸獵鬱鏇網憲網) = 簾鏇窪齋鏇網鬱鏇襯夢 餘選襯鏇鹽簾繭淵襯壓 (觸範淵襯鹹遞獵餘繭壓 ) 更多 | 积极 | 2024-09-30 | ||
临床2期 | 52 | Anlotinib 12 mg once daily | 鬱鏇鹽廠選鹽獵齋廠壓(衊憲簾顧願鏇鑰遞築鏇) = 蓋簾範壓簾壓製壓積襯 壓鹽築夢網窪構積窪構 (積蓋艱艱艱獵齋齋遞蓋 ) 更多 | 积极 | 2024-09-27 |
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