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

NCT00866970 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2020-07-09

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Jeffrey TL Smith, MD FRCP · Alder Biopharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-08-31
Completion
2009-12-31

Countries

  • Australia
  • Canada
  • Georgia
  • India
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Serbia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00866970 on ClinicalTrials.gov