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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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NSCLC, Fatigue, Cachexia

Intervention / Treatment
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* Biological: ALD518
* Biological: ALD518
* Biological: ALD518
* Biological: Infusion of 0.9% Saline without ALD518


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ALD518 | Biological: ALD518<br>* ALD518 80 mg on Day 1, Week 8 and Week 16<br>|
| Experimental: 2<br>ALD518 | Biological: ALD518<br>* ALD518 160 mg IV on Day 1, Week 8 and Week 16<br>|
| Experimental: 3<br>ALD518 | Biological: ALD518<br>* ALD518 360 mg IV on Day 1, Week 8, and Week 16<br>|
| Placebo Comparator: 4<br>No ALD518 | Biological: Infusion of 0.9% Saline without ALD518<br>* Infusion of 0.9% Saline without addition of ALD518<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Safety parameters. |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to symptomatic progressions at Weeks 12 and 24 |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Fatigue, Cachexia