Urothelial carcinoma with locally advanced or metastatic disease
Conditions
Interventions
Administration of anamorelin
Sponsors
Naiki Taku
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with locally advanced or metastatic urothelial carcinoma who are ineligible for curative resection and for whom systemic chemotherapy is indicated 2) Patients receiving systemic chemotherapy with the combination of enfortumab vedotin and pembrolizumab (regardless of 3-weekly or 6-weekly regimen) 3) Patients for whom written informed consent has been obtained from the patient regarding participation in this study 4)Patients aged 20 years or older 5) Patients with a Performance Status (ECOG) of 2 or less
Exclusion criteria
Exclusion criteria: 1) Patients with a history of surgical procedures that clearly influenced weight loss within the past 6 months, or patients scheduled for surgical procedures 2) Patients with a history of hypersensitivity to anamorelin 3) Patients with congestive heart failure 4) Patients with myocardial infarction or angina pectoris 5) Patients with severe conduction system disorders (e.g., complete atrioventricular block) 6)Patients currently taking clarithromycin, itraconazole, voriconazole, ritonavir-containing formulations, cobicistat-containing formulations, or ensitrelvir fumarate 7) Patients with moderate or severe hepatic impairment (Child-Pugh classification B and C) 8)Patients with difficulty in oral food intake due to organic abnormalities of the gastrointestinal tract, such as gastrointestinal obstruction 9) Patients with poorly controlled diabetes 10) Other patients deemed unsuitable as study subjects by the principal investigator/co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether weight loss exceeded 5% during the trial period (24 weeks). Whether weight loss exceeded 2% in subjects with a baseline BMI below 20. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in lean body mass and body weight at each assessment time point Change in score from baseline on the FAACT Anorexia/Cachexia Subscale Domain questionnaire Change from baseline in biomarkers (IGF-1, prealbumin) at each assessment time point Overall survival Progression-free survival Response rate Disease control rate | — |
Contacts
Public ContactTaku Naiki
Nagoya City University West Medical Center
Outcome results
None listed