Ocular toxicity of investigational anti-cancer drugs in early phase clinical trials [0.03%]
早期临床试验中抗癌新药的眼毒性研究
Shigemasa Takamizawa,Yuki Katsuya,Yi-Ning Chen et al.
Shigemasa Takamizawa et al.
Ocular toxicities arising from anti-cancer drugs occur sporadically and are sometimes underestimated because they are not life-threatening. Reports focusing on ocular toxicities from cancer therapy are limited. We investigated the detailed ...
A prospective multicenter phase II study of FOLFIRINOX as a first-line treatment for patients with advanced and recurrent biliary tract cancer [0.03%]
FOLFIRINOX作为一线治疗用于晚期和复发的胆道癌患者的二期多中心前瞻性研究
Naminatsu Takahara,Yousuke Nakai,Hiroyuki Isayama et al.
Naminatsu Takahara et al.
Given the promising activity and tolerability of FOLFIRINOX as a second-line treatment for advanced biliary tract cancer (BTC), it can be an attractive first-line treatment option as well. This is a single-arm, open-label, multicenter phase...
Clinical Trial
Investigational new drugs. 2023 Feb;41(1):76-85. DOI:10.1007/s10637-022-01322-7 2023
Pharmacokinetics and bioequivalence of two pomalidomide capsules in healthy chinese subjects under fasting and fed conditions [0.03%]
空腹和餐后状态下两种来那度胺胶囊在中国健康受试者体内的药代动力学及生物等效性研究
Zhengzhi Liu,Zhongnan Xu,Zhenyue Gao et al.
Zhengzhi Liu et al.
Objective: Imnovid® is an immunomodulatory drug with antineoplastic activity. The aim of this study was to evaluate the bioequivalence and safety of the generic drug pomalidomide (Chia Tai Tianqing Pharmaceutical Group C...
An open label phase II study of safety and clinical activity of naltrexone for treatment of hormone refractory metastatic breast cancer [0.03%]
关于纳曲酮治疗激素抵抗的转移性乳腺癌的安全性和临床效果的开放标签二期研究
Jayanthi Vijayakumar,Tufia Haddad,Kalpna Gupta et al.
Jayanthi Vijayakumar et al.
The opioid receptor (OR) antagonist naltrexone inhibits estrogen receptor-α (ER) function in model systems. The goal of this study was to determine the clinical activity of naltrexone in patients with ER-positive metastatic breast cancer. ...
Clinical Trial
Investigational new drugs. 2023 Feb;41(1):70-75. DOI:10.1007/s10637-022-01317-4 2023
A phase 1 open-label study to assess the relative bioavailability of TAK-931 tablets in reference to powder-in-capsule in patients with advanced solid tumors [0.03%]
在患有晚期实体瘤的患者中进行1期开放标签研究以评估TAK-931片剂相对于粉剂胶囊的相对生物利用度
Neeltje Steeghs,Melinda Pruis,Carla van Herpen et al.
Neeltje Steeghs et al.
In this phase 1 open-label study, we assessed the relative bioavailability of a prototype tablet formulation of TAK-931, a cell division cycle 7 kinase inhibitor, in reference to the current powder-in-capsule (PIC) formulation in patients w...
Clinical Trial
Investigational new drugs. 2023 Feb;41(1):53-59. DOI:10.1007/s10637-022-01318-3 2023
Icotinib, an EGFR tyrosine kinase inhibitor, as adjuvant therapy for patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma: a multicenter, open-label, single-arm, phase II study (ICAPE) [0.03%]
伊克替尼，一种EGFR酪氨酸激酶抑制剂，作为EGFR突变的IIA-IIIA期非小细胞肺癌腺癌患者的辅助治疗：一项多中心、开放标签、单臂、二期研究(ICAPE)
Kun Qian,Qi-Rui Chen,Ming He et al.
Kun Qian et al.
The survival benefit of icotinib (an oral epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor) in patients with advanced lung cancer has been confirmed in several studies. This study (ICAPE) evaluated the efficacy of icotinib ...
Clinical Trial
Investigational new drugs. 2023 Feb;41(1):44-52. DOI:10.1007/s10637-022-01316-5 2023
Predictive performance of PD-L1 tumor proportion score for nivolumab response evaluated using archived specimens in patients with non-small cell lung cancer experiencing a postoperative recurrence [0.03%]
存档样本在评估非小细胞肺癌术后复发患者使用nivolumab治疗反应的PD-L1肿瘤比例评分预测性能中的应用
Yusuke Shima,Yuki Sato,Takeshi Morimoto et al.
Yusuke Shima et al.
Objectives: Postoperative recurrence in patients with non-small-cell lung carcinoma (NSCLC) is a major issue for life expectancy. Programmed cell death ligand 1 (PD-L1) expression on tumor cells is important in the progno...
Phase 1 study of the safety, pharmacokinetics, and preliminary efficacy of CA102N as monotherapy and in combination with trifluridine-tipiracil in patients with locally advanced or metastatic solid tumors [0.03%]
CA102N单药及与 trifluridine-tipiracil 联合治疗局部晚期或转移性实体瘤患者的 I 期研究：安全性、药代动力学和初步疗效分析
Shubham Pant,Tomislav Dragovich,Christopher Lieu et al.
Shubham Pant et al.
CA102N is a covalently bound conjugate of modified nimesulide (Nim) and NaHA, the sodium salt of hyaluronic acid (HA). HA is a natural ligand of cluster of differentiation 44 (CD44), which is over-expressed in colorectal cancer (CRC). CA102...
Clinical Trial
Investigational new drugs. 2023 Feb;41(1):25-34. DOI:10.1007/s10637-022-01308-5 2023
The influence of verapamil on the pharmacokinetics of the pan-HER tyrosine kinase inhibitor neratinib in rats: the role of P-glycoprotein-mediated efflux [0.03%]
维拉帕米对大鼠中泛HER酪氨酸激酶抑制剂奈拉替尼的药代动力学的影响：P-糖蛋白介导的外排的作用
Defei Qi,Yuanyuan Dou,Wenke Zhang et al.
Defei Qi et al.
Neratinib, an irreversible pan-HER tyrosine kinase inhibitor, has been approved for the treatment of HER2-positive (HER2+) early-stage and brain metastatic breast cancer. Thus far, the pharmacology effects and pharmacodynamics of neratinib ...
Oral formulation of bendamustine hydrochloride for patients with advanced solid tumors; a phase 1 study [0.03%]
盐酸苯达莫司汀口服制剂用于晚期实体瘤患者；一项一期研究
Toshio Shimizu,Kazuhiko Nakagawa,Hidetoshi Hayashi et al.
Toshio Shimizu et al.
To determine the maximum tolerated dose (MTD) and recommended dose (RD) of orally-administered bendamustine in Japanese patients with advanced solid tumors. The optimal dosing schedule, safety, pharmacokinetics, and preliminary antitumor ef...
Clinical Trial
Investigational new drugs. 2023 Feb;41(1):1-12. DOI:10.1007/s10637-022-01307-6 2023