NCT00622193

Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Anamorelin HCl Dose Range Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Helsinn Therapeutics (U.S.), Inc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.

Detailed description

Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	anamorelin HCl	50 mg tablet
DRUG	anamorelin HCl	100 mg tablet
DRUG	placebo	placebo tablet

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-02-22
• Last updated: 2017-04-14

Locations

33 sites across 2 countries: United States, India