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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00700180
Registration number
NCT00700180
Ethics application status
Date submitted
17/06/2008
Date registered
18/06/2008
Date last updated
25/09/2014
Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.
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Scientific title
A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy
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Secondary ID [1]
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2008-000662-23
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Secondary ID [2]
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BO21015
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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-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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Lung - Non small cell
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Cancer
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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 - bevacizumab [Avastin]
Treatment: Drugs - bevacizumab [Avastin]
Treatment: Drugs - Carboplatin-based chemotherapy
Experimental: 1 -
Experimental: 2 -
Treatment: Drugs: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle
Treatment: Drugs: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle
Treatment: Drugs: Carboplatin-based chemotherapy
As prescribed
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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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Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level
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Assessment method [1]
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Overall response was analyzed and correlated within dichotomized (low- and high-level) baseline plasma biomarker (basic fibroblast growth factor \[bFGF\], E-selection, intracellular adhesion molecule \[ICAM\], placental growth factor \[PlGF\], vascular endothelial growth factor A \[VEGF A\], vascular endothelial growth factor receptor \[VEGFR\]-1, and VEGFR-2) subgroups: low-level equals (=) less than or equal to (=) median baseline level, high-level=greater than (\>) median baseline level. Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.0 CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR defined as greater than or equal to (=)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease; no new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after criteria for response were first met
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Timepoint [1]
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Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.
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Secondary outcome [1]
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Progression-Free Survival - Percentage of Participants With an Event
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Assessment method [1]
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PFS was defined as the time between randomization and progressive disease (PD) according to RECIST criteria, or death due to any cause. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. Disease progression was evaluated according to the RECIST using computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization.
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Timepoint [1]
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Baseline, Day 1, weekly to disease progression
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Secondary outcome [2]
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Progression-Free Survival - Time to Event
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Assessment method [2]
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PFS was defined as the time between randomization and disease progression or death due to any cause. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization. Disease progression was evaluated according to the RECIST using CT scans, MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method.
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Timepoint [2]
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Baseline, Day 1, weekly to disease progression
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Secondary outcome [3]
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Percentage of Participants With Objective Response
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Assessment method [3]
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Percentage of participants with CR or PR according to RECIST criteria. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as =30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses were confirmed no less than 4 weeks after the criteria for response were first met.
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Timepoint [3]
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Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
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Secondary outcome [4]
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Percentage of Participants With Measurable Disease at Baseline Who Achieved CR, PR, or Stable Disease (SD) for at Least 6 Weeks
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Assessment method [4]
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Percentage of participants with measurable disease at baseline who on assessment achieved CR, PR, or SD according to RECIST. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as =30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met. For participants with SD, follow-up assessments must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.
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Timepoint [4]
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Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
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Secondary outcome [5]
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Duration of Response - Percentage of Participants With an Event
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Assessment method [5]
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Duration of response is defined as time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR).
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Timepoint [5]
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Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
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Secondary outcome [6]
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Duration of Response - Time to Event
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Assessment method [6]
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The median time, in months, from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR). Median Duration of Response was estimated using the Kaplan-Meier method.
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Timepoint [6]
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Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.
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Secondary outcome [7]
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Overall Survival - Percentage of Participants With an Event
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Assessment method [7]
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Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.
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Timepoint [7]
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Baseline, weekly to 28 days after last dose of study treatment, every 8 weeks thereafter to death due to any cause
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Secondary outcome [8]
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Overall Survival - Time to Event
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Assessment method [8]
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Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.
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Timepoint [8]
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Baseline, weekly to death due to any cause, or to end of study
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Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* locally advanced metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC);
* >=1 measurable tumor lesion;
* ECOG performance status 0-1.
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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 anti-cancer agent;
* evidence of CNS metastases;
* history of grade 2 or higher hemoptysis;
* evidence of tumor invading or abutting major blood vessels;
* malignancies other than NSCLC within 5 years prior to randomization, other than adequately treated cancer in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS;
* clinically significant cardiovascular disease;
* current or recent use of aspirin (>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
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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 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
1/09/2012
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Sample size
Target
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Accrual to date
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Final
303
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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- St. Leonards
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Recruitment hospital [2]
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- Adelaide
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Recruitment hospital [3]
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- Box Hill
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Recruitment hospital [4]
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- Fitzroy
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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5041 - Adelaide
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Recruitment postcode(s) [3]
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5065 - Adelaide
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment outside Australia
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Belgium
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Antwerpen
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Belgium
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Liege
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Canada
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British Columbia
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Canada
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Ontario
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Czech Republic
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Ostrava
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Czech Republic
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Praha
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Denmark
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Odense
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France
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Paris
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France
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Rouen
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Germany
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Bad Berka
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Germany
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Grosshansdorf
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Germany
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Hamburg
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Germany
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Oldenburg
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Edeleny
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Hungary
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Sopron
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Hungary
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Szombathely
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Hungary
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Torokbalint
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Italy
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Milano
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Italy
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Milan
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Italy
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Orbassano
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Italy
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Den Haag
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Enschede
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Hoorn
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Nieuwegein
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Rotterdam
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Poznan
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Warszawa
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Zabrze
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St Petersburg
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Spain
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Vizcaya
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Changhua
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
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Aberdeen
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United Kingdom
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Chelmsford
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United Kingdom
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London
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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Trial website
https://clinicaltrials.gov/study/NCT00700180
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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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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for public queries
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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/NCT00700180
Download to PDF