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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00866970
Registration number
NCT00866970
Ethics application status
Date submitted
20/03/2009
Date registered
23/03/2009
Date last updated
9/07/2020
Titles & IDs
Public title
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
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Scientific title
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
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Secondary ID [1]
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ALD518-CLIN-004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
NSCLC
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Fatigue
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Cachexia
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Diet and Nutrition
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - ALD518
Other interventions - ALD518
Other interventions - ALD518
Other interventions - Infusion of 0.9% Saline without ALD518
Experimental: 1 - ALD518
Experimental: 2 - ALD518
Experimental: 3 - ALD518
Placebo Comparator: 4 - No ALD518
Other interventions: ALD518
ALD518 80 mg on Day 1, Week 8 and Week 16
Other interventions: ALD518
ALD518 160 mg IV on Day 1, Week 8 and Week 16
Other interventions: ALD518
ALD518 360 mg IV on Day 1, Week 8, and Week 16
Other interventions: Infusion of 0.9% Saline without ALD518
Infusion of 0.9% Saline without addition of ALD518
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Safety parameters.
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Assessment method [1]
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Timepoint [1]
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20 weeks
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Secondary outcome [1]
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Time to symptomatic progressions at Weeks 12 and 24
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Assessment method [1]
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Timepoint [1]
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24 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2009
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Sample size
Target
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Accrual to date
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Final
124
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Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS
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Recruitment hospital [1]
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Rivercity Hospital Research Centre - Auchenflower
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Recruitment hospital [2]
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Australian Clinical Research Organisation - Kippa Ring
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Palliative Care Launceston General Hospital - Launceston
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Recruitment postcode(s) [1]
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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4021 - Kippa Ring
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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7250 - Launceston
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Recruitment outside Australia
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Canada
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Alberta
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Canada
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New Brunswick
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Canada
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Quebec
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Georgia
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Tbilisi
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India
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Bihar
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India
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Chennai
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India
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Coimbatore
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India
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Maharashtra
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India
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Bangalore
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India
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Gujarat
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India
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Hyderabad
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India
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Jaipur
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India
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Kolkata
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India
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Mumbai
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India
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Patna
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India
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Pune
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New Zealand
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Tauranga
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Poland
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Bydgoszcz
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Poland
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Gdynia
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Poland
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Krakow
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Poland
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Szczecin
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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Oradea
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Romania
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Sibiu
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Russian Federation
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Krasnodar Territory
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Russian Federation
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Republic Of Bashkortostan
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Russian Federation
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Stavropol Territory
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Sremska
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00866970
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jeffrey TL Smith, MD FRCP
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Address
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Alder Biopharmaceuticals, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00866970
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