NCT00866970

Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia

A Phase II Study to Determine the Safety, Efficacy, and Pharmacokinetics of Multiple Intravenous Doses of ALD518 80 mg, 160 mg, and 320 mg Versus Placebo Administered to Patients With Non-Small Cell Lung Cancer-Related Fatigue and Cachexia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).

Detailed description

This is a phase II, double-blind, randomized, placebo-controlled study of ALD518 in patients with NSCLC related fatigue and cachexia. It is estimated that a total of 120 patients will be randomized to ALD518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio. A total of eight visits (excluding the Screening visit) will take place over a period of 24 weeks: Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24. Enrolled patients will be screened within a 4 week period (Day 35 to 7). Randomization to treatment will be within a 12 day period (Day 14 to 3), before initial dosing on Day 1. Patients will receive treatment eight weeks apart (on Day 1, and Weeks 8 and 16). All patients will remain at the clinic for at least 4 hours from the time the infusion is started. Follow-up visits will occur four and eight weeks after the last dose of study drug, at Weeks 20 and 24, respectively.

Conditions

• NSCLC
• Fatigue
• Cachexia

Interventions

Type	Name	Description
BIOLOGICAL	ALD518	ALD518 80 mg on Day 1, Week 8 and Week 16
BIOLOGICAL	ALD518	ALD518 160 mg IV on Day 1, Week 8 and Week 16
BIOLOGICAL	ALD518	ALD518 360 mg IV on Day 1, Week 8, and Week 16
BIOLOGICAL	Infusion of 0.9% Saline without ALD518	Infusion of 0.9% Saline without addition of ALD518

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-08-01
• Completion: 2009-12-01
• First posted: 2009-03-23
• Last updated: 2020-07-09

Locations

43 sites across 9 countries: Australia, Canada, Georgia, India, New Zealand, Poland, Romania, Russia, Serbia