NCT01395914

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 513 (actual)
• Sponsor: Helsinn Therapeutics (U.S.), Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Detailed description

This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.

Conditions

• Cachexia
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anamorelin HCl
DRUG	Placebo

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-06-01
• Completion: 2015-02-01
• First posted: 2011-07-18
• Last updated: 2017-09-14
• Results posted: 2017-07-11

Locations

72 sites across 17 countries: United States, Australia, Belarus, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Russia, Serbia, Slovenia, Spain, Ukraine