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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00451906
Registration number
NCT00451906
Ethics application status
Date submitted
22/03/2007
Date registered
26/03/2007
Date last updated
24/05/2016
Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
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Scientific title
Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
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Secondary ID [1]
0
0
MO19390
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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
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Lung - Mesothelioma
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Cancer
0
0
0
0
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Lung - Non small cell
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Cancer
0
0
0
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 - Platinum-based chemotherapy
Treatment: Drugs - Bevacizumab [Avastin]
Experimental: Bevacizumab + Chemotherapy - Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.
Treatment: Drugs: Platinum-based chemotherapy
As prescribed
Treatment: Drugs: Bevacizumab [Avastin]
15 mg/kg IV on Day 1 of each 3 week cycle
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Intervention code [1]
0
0
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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Number of Participants With Adverse Events of Special Interest
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Assessment method [1]
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0
Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.
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Timepoint [1]
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0
Up to 3 years
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Primary outcome [2]
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0
Number of Participants With Serious Adverse Events Related to Bevacizumab
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Assessment method [2]
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Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [1]
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0
Duration of Overall Survival
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Assessment method [1]
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Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.
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Timepoint [1]
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0
Up to 3 years
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Secondary outcome [2]
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Time to Disease Progression
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Assessment method [2]
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Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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0
Number of Participants With Central Nervous System Bleeding
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Assessment method [3]
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The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.
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Timepoint [3]
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Up to 3 years
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Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
* ECOG PS status 0-2;
* life expectancy >= 12weeks;
* adequate renal, liver and hematological function.
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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
* mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
* hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
* evidence of tumor invading major blood vessels on imaging;
* evidence of CNS metastases, even if previously treated.
* major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
* prior chemotherapy for stage IIIb/IV disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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Other design features
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Phase
Phase 4
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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
1/08/2006
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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
1/06/2009
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Sample size
Target
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Accrual to date
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Final
2252
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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- St. Leonards
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- Waratah
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- Auchenflower
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- Chermside
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- Tugun
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- Box Hill
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- Geelong
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- Malvern
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- Wodonga
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- Perth
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- Sydney, New South Wales
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2065 - St. Leonards
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2298 - Waratah
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4066 - Auchenflower
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4032 - Chermside
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4224 - Tugun
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3128 - Box Hill
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3220 - Geelong
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3144 - Malvern
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3690 - Wodonga
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6008 - Perth
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2077 - Sydney, New South Wales
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Recruitment outside Australia
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Argentina
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Tiel
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Braga
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Portugal
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Porto
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Portugal
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Santa Maria Da Feira
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Portugal
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Setubal
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Portugal
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Vila Nova De Gaia
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Bucharest
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Cluj Napoca
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Romania
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Timisoara
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Russian Federation
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Engels
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Russian Federation
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Irkutsk
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Russian Federation
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Russian Federation
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Krasnodar
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Samara
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Stavropol
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Tumen
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Russian Federation
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Tver
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Ulyanovsk
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Belgrade
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
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Summary
Brief summary
This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.
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Trial website
https://clinicaltrials.gov/study/NCT00451906
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Trial related presentations / publications
Bearz A, Passalacqua R, Alabiso O, Cinieri S, Gridelli C, Cravesana C, Crino L. First-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer : analysis of the Italian patients enrolled in the SAiL study. Clin Drug Investig. 2012 Nov;32(11):755-60. doi: 10.1007/s40261-012-0001-9. Crino L, Dansin E, Garrido P, Griesinger F, Laskin J, Pavlakis N, Stroiakovski D, Thatcher N, Tsai CM, Wu YL, Zhou C. Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study. Lancet Oncol. 2010 Aug;11(8):733-40. doi: 10.1016/S1470-2045(10)70151-0. Epub 2010 Jul 23.
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Public notes
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Contacts
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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 are available at
https://clinicaltrials.gov/study/NCT00451906
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