NCT01387282

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 495 (actual)
• Sponsor: Helsinn Therapeutics (U.S.), Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function.

Conditions

• Cachexia
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anamorelin HCl	Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal
DRUG	Placebo	Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-11-01
• Completion: 2015-02-01
• First posted: 2011-07-04
• Last updated: 2017-10-27
• Results posted: 2017-07-11

Locations

46 sites across 7 countries: United States, Australia, Hungary, Israel, Poland, Russia, United Kingdom