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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 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 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 13 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01387282
The ClinicalTrials.gov registry entry for NCT01387282 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 495 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (25% lower). The listed sponsor is Helsinn Therapeutics (U.S.), which has 10 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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