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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)
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
Secondary ID [1] 0 0
BO17704
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer 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

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Event driven
Secondary outcome [1] 0 0
Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.
Timepoint [1] 0 0
Event driven
Secondary outcome [2] 0 0
Safety:AEs, laboratory tests, SAEs, coagulation parameters
Timepoint [2] 0 0
Throughout study

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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
1044
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Canberra
Recruitment hospital [4] 0 0
- Kurralta Park
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Parkville
Recruitment hospital [7] 0 0
- Perth
Recruitment hospital [8] 0 0
- Sydney
Recruitment hospital [9] 0 0
- Tugun
Recruitment hospital [10] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
5065 - Adelaide
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
2606 - Canberra
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [6] 0 0
3128 - Melbourne
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Perth
Recruitment postcode(s) [9] 0 0
2050 - Sydney
Recruitment postcode(s) [10] 0 0
2139 - Sydney
Recruitment postcode(s) [11] 0 0
4224 - Tugun
Recruitment postcode(s) [12] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Bahia Blanca
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Mendoza
Country [4] 0 0
Argentina
State/province [4] 0 0
San Miguel de Tucuman
Country [5] 0 0
Argentina
State/province [5] 0 0
Santa Fe
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Haine-saint-paul
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Liege
Country [10] 0 0
Brazil
State/province [10] 0 0
Belo Horizonte
Country [11] 0 0
Brazil
State/province [11] 0 0
Porto Alegre
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio de Janeiro
Country [13] 0 0
Brazil
State/province [13] 0 0
Sao Paulo
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Plovdiv
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Stara Zagora
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Varna
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Veliko Tarnovo
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
New Brunswick
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Ostrava
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Praha
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Usti Nad Labem
Country [27] 0 0
France
State/province [27] 0 0
Belfort
Country [28] 0 0
France
State/province [28] 0 0
Bobigny
Country [29] 0 0
France
State/province [29] 0 0
Caen
Country [30] 0 0
France
State/province [30] 0 0
Lyon
Country [31] 0 0
France
State/province [31] 0 0
Marseille
Country [32] 0 0
France
State/province [32] 0 0
Montbeliard
Country [33] 0 0
France
State/province [33] 0 0
Montpellier
Country [34] 0 0
France
State/province [34] 0 0
Pierre Benite
Country [35] 0 0
France
State/province [35] 0 0
Rennes
Country [36] 0 0
France
State/province [36] 0 0
Rouen
Country [37] 0 0
France
State/province [37] 0 0
St Herblain
Country [38] 0 0
France
State/province [38] 0 0
Strasbourg
Country [39] 0 0
France
State/province [39] 0 0
Vandoeuvre Les Nancy
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Essen
Country [42] 0 0
Germany
State/province [42] 0 0
Gauting
Country [43] 0 0
Germany
State/province [43] 0 0
Göttingen
Country [44] 0 0
Germany
State/province [44] 0 0
Hamburg
Country [45] 0 0
Germany
State/province [45] 0 0
Heidelberg
Country [46] 0 0
Germany
State/province [46] 0 0
Hemer
Country [47] 0 0
Germany
State/province [47] 0 0
Karlsruhe
Country [48] 0 0
Germany
State/province [48] 0 0
Leverkusen
Country [49] 0 0
Germany
State/province [49] 0 0
Mainz
Country [50] 0 0
Germany
State/province [50] 0 0
Mannheim
Country [51] 0 0
Germany
State/province [51] 0 0
München
Country [52] 0 0
Greece
State/province [52] 0 0
Alexandroupolis
Country [53] 0 0
Greece
State/province [53] 0 0
Athens
Country [54] 0 0
Greece
State/province [54] 0 0
Thessaloniki
Country [55] 0 0
Hong Kong
State/province [55] 0 0
Hong Kong
Country [56] 0 0
Hungary
State/province [56] 0 0
Budapest
Country [57] 0 0
Hungary
State/province [57] 0 0
Mosdos
Country [58] 0 0
Hungary
State/province [58] 0 0
Nyiregyhaza
Country [59] 0 0
Hungary
State/province [59] 0 0
Szekesfehervar
Country [60] 0 0
Hungary
State/province [60] 0 0
Szombathely
Country [61] 0 0
Hungary
State/province [61] 0 0
Zalaegerszeg
Country [62] 0 0
Israel
State/province [62] 0 0
Jerusalem
Country [63] 0 0
Israel
State/province [63] 0 0
Kfar Saba
Country [64] 0 0
Israel
State/province [64] 0 0
Petach Tikva
Country [65] 0 0
Israel
State/province [65] 0 0
Ramat-gan
Country [66] 0 0
Israel
State/province [66] 0 0
Tel Aviv
Country [67] 0 0
Italy
State/province [67] 0 0
Candiolo
Country [68] 0 0
Italy
State/province [68] 0 0
Catania
Country [69] 0 0
Italy
State/province [69] 0 0
Genova
Country [70] 0 0
Italy
State/province [70] 0 0
Milano
Country [71] 0 0
Italy
State/province [71] 0 0
Napoli
Country [72] 0 0
Italy
State/province [72] 0 0
Parma
Country [73] 0 0
Italy
State/province [73] 0 0
Perugia
Country [74] 0 0
Italy
State/province [74] 0 0
Reggio Emilia
Country [75] 0 0
Italy
State/province [75] 0 0
Roma
Country [76] 0 0
Italy
State/province [76] 0 0
Rozzano
Country [77] 0 0
Poland
State/province [77] 0 0
Gdansk
Country [78] 0 0
Poland
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Gdynia
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Poland
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Lublin
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Poland
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Olsztyn
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Poland
State/province [81] 0 0
Poznan
Country [82] 0 0
Poland
State/province [82] 0 0
Szczecin
Country [83] 0 0
Poland
State/province [83] 0 0
Warszawa
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Balashikha
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Moscow
Country [86] 0 0
Russian Federation
State/province [86] 0 0
St Petersburg
Country [87] 0 0
Spain
State/province [87] 0 0
Alicante
Country [88] 0 0
Spain
State/province [88] 0 0
Barakaldo
Country [89] 0 0
Spain
State/province [89] 0 0
Barcelona
Country [90] 0 0
Spain
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Girona
Country [91] 0 0
Spain
State/province [91] 0 0
La Laguna
Country [92] 0 0
Spain
State/province [92] 0 0
Madrid
Country [93] 0 0
Spain
State/province [93] 0 0
Málaga
Country [94] 0 0
Spain
State/province [94] 0 0
Sevilla
Country [95] 0 0
Spain
State/province [95] 0 0
Valencia
Country [96] 0 0
Taiwan
State/province [96] 0 0
Kueishan
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taichung
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taipei
Country [99] 0 0
Thailand
State/province [99] 0 0
Bangkok
Country [100] 0 0
Thailand
State/province [100] 0 0
Chiang Mai
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Guildford
Country [102] 0 0
United Kingdom
State/province [102] 0 0
London
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Manchester
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Sheffield
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Sutton
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Yeovil

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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/NCT00806923