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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00866970

Enrollment

124

Registered

2009-03-23

Start date

2008-09-30

Completion date

2009-12-31

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cachexia, Fatigue, NSCLC

Keywords

Lung Cancer, Fatigue, Cachexia

Brief 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.

Interventions

BIOLOGICALALD518

ALD518 80 mg on Day 1, Week 8 and Week 16

BIOLOGICALInfusion of 0.9% Saline without ALD518

Infusion of 0.9% Saline without addition of ALD518

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed diagnosis of NSCLC incurable by other treatments including surgery * A ≥5 % loss of body weight in the preceding 3 months * A C-reactive protein (CRP) concentration ≥ 10 mg/L * Life Expectancy of at least 12 weeks

Exclusion criteria

* Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days * AST/ALT ≥ 3 x ULN at screening * Hemoglobin \< 8 g/dL at Screening * History of or active diagnosis of Tuberculosis

Design outcomes

Primary

Measure	Time frame
Change in Safety parameters.	20 weeks

Secondary

Measure	Time frame
Time to symptomatic progressions at Weeks 12 and 24	24 weeks

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026