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
18 Years
N/A
Both
NSCLC, Fatigue, Cachexia
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Change in Safety parameters.
Outcome Time Frame:
20 weeks
Safety Issue:
Yes
Principal Investigator
Jeffrey TL Smith, MD FRCP
Investigator Role:
Study Director
Investigator Affiliation:
Alder Biopharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
ALD518-CLIN-004
NCT ID:
NCT00866970
Start Date:
September 2008
Completion Date:
December 2009
Related Keywords:
- NSCLC
- Fatigue
- Cachexia
- Lung Cancer
- Fatigue
- Cachexia
- Cachexia
- Carcinoma, Non-Small-Cell Lung
- Fatigue
- Lung Neoplasms
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