urothelial carcinoma
Conditions
Interventions
Anamorelin group:Daily oral anamorelin (100mg) for 12 weeks from the start of systemic chemotherapy
Control group:Systemic chemotherapy
Sponsors
Naiki Taku
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in prealbumin at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change 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 | — |
Contacts
Public ContactTaku Naiki
Nagoya City University Hospital
Outcome results
None listed