# Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)

> **NCT01387269** · PHASE3 · COMPLETED · sponsor: **Helsinn Therapeutics (U.S.), Inc** · enrollment: 484 (actual)

## Conditions studied

- Cachexia
- Non-Small Cell Lung Cancer

## Interventions

- **DRUG:** Anamorelin HCl
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01387269
- **Lead sponsor:** Helsinn Therapeutics (U.S.), Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-07
- **Primary completion:** 2014-01
- **Final completion:** 2015-02
- **Target enrollment:** 484 (ACTUAL)
- **Last updated:** 2017-10-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01387269

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01387269, "Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT01387269. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
