JPRN-UMIN000050878RecruitingUnknown
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) - Prospective observational study of anamorelin in patients with previously-untreated advanced non-small cell lung cancer and cachexia (NEJ050B)
orth East Japan Study Group (NEJSG)0 sites135 target enrollmentStarted: April 18, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 135
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(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.
Investigators
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