NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041210041

Registered date:15/07/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedurothelial carcinoma
Date of first enrollment19/07/2021
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)Anamorelin group:Daily oral anamorelin (100mg) for 12 weeks from the start of systemic chemotherapy Control group:Systemic chemotherapy

Outcome(s)

Primary OutcomeChange from baseline in prealbumin at Week 12
Secondary OutcomeChange from baseline in prealbumin at each evaluation time point, change from baseline in GNRI at each evaluation time point, change from baseline in albumin level at each evaluation time point, change from baseline in IGF-1 and IGFBP-3 at each evaluation time point, change from baseline in body weight at each evaluation time point, change from baseline in body weight at each time point, overall survival

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Taku Naiki
Address 1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi Aichi Japan 467-8602
Telephone +81-52-853-8266
E-mail naiki@med.nagoya-cu.ac.jp
Affiliation Nagoya City University Hospital
Scientific contact
Name Taku Naiki
Address 1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi Aichi Japan 467-8602
Telephone +81-52-853-8266
E-mail naiki@med.nagoya-cu.ac.jp
Affiliation Nagoya City University Hospital