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NCT01387269 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
A Phase 3 study, sponsored by Helsinn Therapeutics (U.S.).
- Completed
- Registry status
- Phase 3
- Development phase
- 484
- Enrollment target
NCT01387269: Completed Phase 3 study, sponsored by Helsinn Therapeutics (U.S.).
NCT01387269 is a Phase 3 study that has completed, run by Helsinn Therapeutics (U.S.). The registered enrollment target is 484 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01387269, a Phase 3 study, has completed, sponsored by Helsinn Therapeutics (U.S.).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 484 participants
- Enrollment target
Study 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.
Primary Outcome
Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
Interventions
- DRUG Placebo
- DRUG Anamorelin HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT01387269 record still lists
NCT01387269 is an interventional study that assigns participants to a tested intervention. The registered 484 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01387269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01387269 about?
NCT01387269 is a clinical study titled "Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)". 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.
What is the current status of trial NCT01387269?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 484 participants. The study started on 2011-07. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01387269?
The interventions under investigation include: Placebo (DRUG), Anamorelin HCl (DRUG).
Who is sponsoring clinical trial NCT01387269?
This trial is sponsored by Helsinn Therapeutics (U.S.), which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01387269's enrollment target sits among peer trials
484 791st of 2000 higher than 1,209 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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