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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00806923
Registration number
NCT00806923
Ethics application status
Date submitted
10/12/2008
Date registered
11/12/2008
Date last updated
2/11/2016
Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC
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Secondary ID [1]
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BO17704
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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:
Non-Squamous Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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0
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Lung - Non small cell
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Cancer
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Placebo
Treatment: Drugs - bevacizumab [Avastin]
Treatment: Drugs - bevacizumab [Avastin]
Experimental: 1 -
Experimental: 2 -
Placebo comparator: 3 -
Treatment: Drugs: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Treatment: Drugs: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Treatment: Drugs: Placebo
iv on day 1 of each 3 week cycle until disease progression
Treatment: Drugs: bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
Treatment: Drugs: bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
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Intervention code [1]
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Treatment: Drugs
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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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Progression-free survival
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Assessment method [1]
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Timepoint [1]
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Event driven
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Secondary outcome [1]
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Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.
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Assessment method [1]
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Timepoint [1]
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Event driven
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Secondary outcome [2]
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Safety:AEs, laboratory tests, SAEs, coagulation parameters
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Assessment method [2]
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Timepoint [2]
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Throughout study
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Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
* adequate liver and kidney function;
* women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.
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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
* prior chemotherapy or treatment with another systemic cancer therapy;
* surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
* brain metastasis or spinal cord compression;
* fertile men, and women of childbearing potential, not using adequate contraception;
* treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/02/2005
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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
1/02/2011
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Sample size
Target
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Accrual to date
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Final
1044
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Recruitment in Australia
Recruitment state(s)
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- Adelaide
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5011 - Adelaide
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5065 - Adelaide
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4029 - Brisbane
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2606 - Canberra
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5037 - Kurralta Park
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3128 - Melbourne
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3052 - Parkville
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6009 - Perth
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2050 - Sydney
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2139 - Sydney
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4224 - Tugun
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2500 - Wollongong
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Ethics approval
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Summary
Brief summary
This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.
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Trial website
https://clinicaltrials.gov/study/NCT00806923
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Trial related presentations / publications
Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18. Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22. Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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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/NCT00806923
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