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NCT01387282 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)
A Phase 3 study of Non-Small Cell Lung Cancer and Cachexia, sponsored by Helsinn Therapeutics (U.S.).
- Completed
- Registry status
- Phase 3
- Development phase
- 495
- Enrollment target
- 20
- Study locations
NCT01387282: Completed Phase 3 study of Non-Small Cell Lung Cancer and Cachexia, sponsored by Helsinn Therapeutics (U.S.).
NCT01387282 is a Phase 3 study of Non-Small Cell Lung Cancer and Cachexia that has completed, run by Helsinn Therapeutics (U.S.). The registered enrollment target is 495 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01387282, a Phase 3 study of Non-Small Cell Lung Cancer and Cachexia, has completed, sponsored by Helsinn Therapeutics (U.S.).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 495 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Anamorelin HCl
Study Locations (20)
California
- - Corona
- - Fountain Valley
- - Glendale
Ohio
- - Cincinnati
- - Cleveland
- - Sylvania
Other
- - Adelaide
- - Budapest
- - Nyíregyháza
Victoria
- - East Bentleigh
- - Parkville
District of Columbia
- - Washington D.C.
Maryland
- - Baltimore
Michigan
- - Detroit
New York
- - Lake Success
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 495 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT01387282 record still lists
NCT01387282 is an interventional study that assigns participants to a tested intervention. The registered 495 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (24% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01387282 names 20 study sites across 13 states, led by California, Ohio, Other.
Frequently Asked Questions
What is clinical trial NCT01387282 about?
NCT01387282 is a clinical study titled "Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)". 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 NCT01387282?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 495 participants. The study started on 2011-07. Estimated completion is 2015-02.
What conditions does trial NCT01387282 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Cachexia.
What interventions are being tested in trial NCT01387282?
The interventions under investigation include: Placebo (DRUG), Anamorelin HCl (DRUG).
Who is sponsoring clinical trial NCT01387282?
This trial is sponsored by Helsinn Therapeutics (U.S.), which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01387282 being conducted?
This trial has 20 study locations across California, District of Columbia, Maryland, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01387282's enrollment target sits among peer trials
495 79th of 454 higher than 376 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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