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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
Treatment: Other - ALD518
Treatment: Other - ALD518
Treatment: Other - ALD518
Treatment: Other - Infusion of 0.9% Saline without ALD518

Experimental: 1 - ALD518

Experimental: 2 - ALD518

Experimental: 3 - ALD518

Placebo comparator: 4 - No ALD518


Treatment: Other: ALD518
ALD518 80 mg on Day 1, Week 8 and Week 16

Treatment: Other: ALD518
ALD518 160 mg IV on Day 1, Week 8 and Week 16

Treatment: Other: ALD518
ALD518 360 mg IV on Day 1, Week 8, and Week 16

Treatment: Other: Infusion of 0.9% Saline without ALD518
Infusion of 0.9% Saline without addition of ALD518
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Safety parameters.
Timepoint [1] 0 0
20 weeks
Secondary outcome [1] 0 0
Time to symptomatic progressions at Weeks 12 and 24
Timepoint [1] 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
Sex
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
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
124
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
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00866970