drugset / Trial / NCT01387269
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
Timeline
- Start
- 2011-07
- Primary completion
- 2014-01
- Completion
- 2015-02
Outcome
Mixed primary results
registry MEDIAN Anamorelin HCl: 0.99 (0.61 to 1.36) kg NCT01387269 ↗
registry MEDIAN Placebo: -0.47 (-1.00 to 0.21) kg NCT01387269 ↗
registry analysis (superiority or other test); Anamorelin HCl vs Placebo; p < 0.0001; Wilcoxon rank sum test NCT01387269 ↗
registry analysis (superiority or other test); Anamorelin HCl vs Placebo; p = 0.1475; Wilcoxon rank sum test NCT01387269 ↗
Publications
- Laird BJA, Skipworth R, Bonomi PD, Fallon M, Kaasa S, Giorgino R, McMillan DC, Currow DC. Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13732. doi: 10.1002/jcsm.13732.
- Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017 Aug 1;28(8):1949-1956. doi: 10.1093/annonc/mdx192.
- Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC. Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016 Apr;17(4):519-531. doi: 10.1016/S1470-2045(15)00558-6. Epub 2016 Feb 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anamorelin | Small molecule | 100 mg | Oral |