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

JRCT ID: jRCTs041210041

Registered date:15/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: urothelial carcinoma
• Date of first enrollment: 19/07/2021
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Anamorelin group:Daily oral anamorelin (100mg) for 12 weeks from the start of systemic chemotherapy
Control group:Systemic chemotherapy

Outcome(s)

• Primary Outcome: Change from baseline in prealbumin at Week 12
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Naiki Taku