Prospective observational study to evaluate the efficacy of anamorelin on the course of first line chemotherapy in patients with previously-untreated advanced non-small cell lung cancer and cachexia (NEJ050B)
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000050878
- Lead Sponsor
- orth East Japan Study Group (NEJSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 135
Not provided
(1) Current use of corticosteroids. (2) Subjects scheduled to receive systemic therapy, but don't fit into cohorts 1, 2, or 3. (3) Subjects with a history of hypersensitivity to anamorelin (4) Subjects with congestive heart failure (5) Subjects with myocardial infarction or angina pectoris (6) Subjects with severe conduction system disorders (such as complete atrioventricular block) (7) Subjects receiving the following drugs: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing products, cobicistat-containing products (8) Subjects with liver dysfunction of more than moderate severity (Child-Pugh class B or C) (9) Subjects with difficulty in oral intake of food due to gastrointestinal obstruction or other organic abnormality of the gastrointestinal tract (10) Subjects who are unable to accurately complete the QOL questionnaire. (11) Subjects who are judged by the principal or sub-investigator to be unsuitable for inclusion in this study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with clinically relevant improvement in FAACT (A/CS) at 3 weeks after the start of first-line chemotherapy
- Secondary Outcome Measures
Name Time Method FAACT (A/CS), Questionnaire for eating-related distress among patients with advanced cancer (QERD), FACT-G, ECOG PS, KPS, body weight, objective response rate, disease control rate, progression-free survival, overall survival, adverse events, Composite Clinical Response (defined as the proportion of patients with an increase in body weight of >= 5 % and an increase in FAACT 5IASS score of >= 2 points at 3 weeks after the start of first-line chemotherapy)