NCT01387269

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)

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: 484 (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. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.

Conditions

• Cachexia
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anamorelin HCl	Anamorelin HCl will be orally administered daily at least one hour before meal
DRUG	Placebo	Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-01-01
• Completion: 2015-02-01
• First posted: 2011-07-04
• Last updated: 2017-10-27
• Results posted: 2017-07-11

Locations

60 sites across 16 countries: United States, Belarus, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Russia, Serbia, Slovenia, Spain, Ukraine