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

Phase 2

Completed

• Conditions: NSCLC; Fatigue; Cachexia

• Registration Number: NCT00866970
• Lead Sponsor: CSL Behring

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Status Verified: 2017-09
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Safety parameters.	20 weeks

Secondary Outcome Measures

Name	Time	Method
Time to symptomatic progressions at Weeks 12 and 24	24 weeks

Trial Locations

Locations (43)

Rivercity Hospital Research Centre; 🇦🇺 Auchenflower, Queensland, Australia

Australian Clinical Research Organisation; 🇦🇺 Kippa Ring, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Palliative Care Launceston General Hospital; 🇦🇺 Launceston, Tasmania, Australia

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Atlantic Health Sciences Corporation; 🇨🇦 Saint John, New Brunswick, Canada

McGill University, Department of Oncology; 🇨🇦 Montreal, Quebec, Canada

A. Gvamichava National Cancer Centre; 🇬🇪 Tbilisi, Georgia

Union Cancer Prevention Centre; 🇬🇪 Tbilisi, Georgia

Medulla Chemotherapy and Immunotherapy Clinic; 🇬🇪 Tbilisi, Georgia

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