Status:
COMPLETED
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
Lead Sponsor:
CSL Behring
Conditions:
NSCLC
Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00866970
Start Date
September 1 2008
End Date
December 1 2009
Last Update
July 9 2020
Active Locations (43)
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1
Rivercity Hospital Research Centre
Auchenflower, Queensland, Australia, 4066
2
Australian Clinical Research Organisation
Kippa-Ring, Queensland, Australia, 4021
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
4
Palliative Care Launceston General Hospital
Launceston, Tasmania, Australia, 7250