The efficacy of anamorelin for the patients with metastatic urothelial carcinoma treated by systemic chemotherapy. - The efficacy of anamorelin for the patients with metastatic urothelial carcinoma treated by systemic chemotherapy.

aiki Taku0 个研究点目标入组 40 人开始时间: 2021年7月15日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Eligible for systemic chemotherapy for urothelial carcinoma with recurrence or distant metastasis
•2) Receive gemcitabine plus cisplatin or gemcitabine plus carboplatin as systemic chemotherapy
•3) Written consent to participate in this study
•4) Male and female patients aged 20 years or older
•5) Performance status (ECOG) of 2 or less

•1) History of surgical procedure that clearly affected weight loss within the past 6 months, or scheduled for surgical procedure
•2) History of hypersensitivity to anamorelin
•3) Congestive heart failure
•4) History of myocardial infarction or angina pectoris
•5) Severe conduction disturbances (e.g., complete atrioventricular block)
•6) Taking clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing products, or cobicistat-containing products
•7) Moderate or severe hepatic dysfunction (Child-Pugh classification B or C)
•8) Difficulty in oral intake of food due to organic abnormality of the gastrointestinal tract such as gastrointestinal obstruction
•9) Diabetic patients with poor control
•10) History of hypersensitivity to gemcitabine
•11) Severe bone marrow suppression
•12) Clinically symptomatic interstitial pneumonia or pulmonary fibrosis evident on plain chest radiograph
•13) Undergoing radiation therapy to the chest
•14) Complicated severe infections
•15) History of hypersensitivity to cisplatin or other platinum-containing drugs
•16) Severe renal impairment
•17) Pregnant women or women who may be pregnant
•18) Other patients who are judged by the principal investigator/associate investigator to be inappropriate as research subjects

发起方

aiki Taku