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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00866970




Registration number
NCT00866970
Ethics application status
Date submitted
20/03/2009
Date registered
20/03/2009
Date last updated
25/09/2017

Titles & IDs
Public title
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
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
Secondary ID [1] 0 0
ALD518-CLIN-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Fatigue 0 0
Cachexia 0 0
NSCLC 0 0
Fatigue 0 0
Cachexia 0 0
NSCLC 0 0
Fatigue 0 0
Cachexia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ALD518
Other interventions - ALD518
Other interventions - ALD518
Other interventions - Infusion of 0.9% Saline without ALD518
Other interventions - ALD518
Other interventions - ALD518
Other interventions - ALD518
Other interventions - Infusion of 0.9% Saline without ALD518
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

Experimental: 1 - ALD518

Experimental: 2 - ALD518

Experimental: 3 - ALD518

Placebo Comparator: 4 - No 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

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

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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Safety parameters.
Timepoint [1] 0 0
20 weeks
Primary outcome [2] 0 0
Change in Safety parameters.
Timepoint [2] 0 0
20 weeks
Primary outcome [3] 0 0
Change in Safety parameters.
Timepoint [3] 0 0
20 weeks
Secondary outcome [1] 0 0
Time to symptomatic progressions at Weeks 12 and 24
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Time to symptomatic progressions at Weeks 12 and 24
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Time to symptomatic progressions at Weeks 12 and 24
Timepoint [3] 0 0
24 weeks

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS
Recruitment hospital [1] 0 0
Rivercity Hospital Research Centre - Auchenflower
Recruitment hospital [2] 0 0
Australian Clinical Research Organisation - Kippa Ring
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Palliative Care Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
7250 - Launceston
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
New Brunswick
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Georgia
State/province [4] 0 0
Tbilisi
Country [5] 0 0
India
State/province [5] 0 0
Bihar
Country [6] 0 0
India
State/province [6] 0 0
Chennai
Country [7] 0 0
India
State/province [7] 0 0
Coimbatore
Country [8] 0 0
India
State/province [8] 0 0
Maharashtra
Country [9] 0 0
India
State/province [9] 0 0
Bangalore
Country [10] 0 0
India
State/province [10] 0 0
Gujarat
Country [11] 0 0
India
State/province [11] 0 0
Hyderabad
Country [12] 0 0
India
State/province [12] 0 0
Jaipur
Country [13] 0 0
India
State/province [13] 0 0
Kolkata
Country [14] 0 0
India
State/province [14] 0 0
Mumbai
Country [15] 0 0
India
State/province [15] 0 0
Patna
Country [16] 0 0
India
State/province [16] 0 0
Pune
Country [17] 0 0
New Zealand
State/province [17] 0 0
Tauranga
Country [18] 0 0
Poland
State/province [18] 0 0
Bydgoszcz
Country [19] 0 0
Poland
State/province [19] 0 0
Gdynia
Country [20] 0 0
Poland
State/province [20] 0 0
Krakow
Country [21] 0 0
Poland
State/province [21] 0 0
Szczecin
Country [22] 0 0
Romania
State/province [22] 0 0
Bucharest
Country [23] 0 0
Romania
State/province [23] 0 0
Cluj-Napoca
Country [24] 0 0
Romania
State/province [24] 0 0
Oradea
Country [25] 0 0
Romania
State/province [25] 0 0
Sibiu
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Krasnodar Territory
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Republic of Bashkortostan
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Stavropol Territory
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Novosibirsk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Saint-Petersburg
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Yaroslavl
Country [32] 0 0
Serbia
State/province [32] 0 0
Belgrade
Country [33] 0 0
Serbia
State/province [33] 0 0
Kragujevac
Country [34] 0 0
Serbia
State/province [34] 0 0
Sremska

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vitaeris INC
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT00866970
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffrey TL Smith, MD FRCP
Address 0 0
Alder Biopharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications