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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01214720




Registration number
NCT01214720
Ethics application status
Date submitted
4/10/2010
Date registered
5/10/2010
Date last updated
13/08/2014

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
Scientific title
A Randomized, Double-blind Study of the Effect of Avastin Plus Gemcitabine and Erlotinib Compared With Placebo Plus Gemcitabine and Erlotinib on Overall Survival in Patients With Metastatic Pancreatic Cancer
Secondary ID [1] 0 0
BO17706
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bevacizumab [Avastin]

Experimental: 1 -


Treatment: Drugs: bevacizumab [Avastin]
Intervenous repeating dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of Overall Survival - Percentage of Participants With an Event
Timepoint [1] 0 0
Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
Primary outcome [2] 0 0
Duration of Overall Survival - Time to Event
Timepoint [2] 0 0
Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
Secondary outcome [1] 0 0
Clinical Benefit Response (CBR)
Timepoint [1] 0 0
Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) - Percentage of Participants With an Event
Timepoint [2] 0 0
Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) - Time to Event
Timepoint [3] 0 0
Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression
Secondary outcome [4] 0 0
Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment
Timepoint [4] 0 0
Baseline and Week 8
Secondary outcome [5] 0 0
Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib
Timepoint [5] 0 0
Weeks 1, 3, 5, 7, and 9

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* metastatic pancreatic cancer (adenocarcinoma);
* good liver, kidney, and bone marrow function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* previous systemic treatment for metastatic pancreatic cancer;
* pregnant or lactating females;
* fertile men, or women of childbearing potential, not using adequate contraception;
* major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
* current or recent treatment (within 30 days prior to starting study treatment) with another investigational drug, or participation in another investigational 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
Blinded (masking 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
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
607
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Footscray
Recruitment hospital [4] 0 0
- Heidelberg
Recruitment hospital [5] 0 0
- Kurralta Park
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- St. Leonards
Recruitment hospital [8] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [6] 0 0
3002 - Melbourne
Recruitment postcode(s) [7] 0 0
3128 - Melbourne
Recruitment postcode(s) [8] 0 0
2065 - St. Leonards
Recruitment postcode(s) [9] 0 0
2031 - Sydney
Recruitment postcode(s) [10] 0 0
2217 - Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Salzburg
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Antwerpen
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
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Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Wilrijk
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Brno
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Czech Republic
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Hradec Kralove
Country [17] 0 0
Finland
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Helsinki
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France
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Besancon
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France
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Bordeaux
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France
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Boulogne-billancourt
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France
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Clichy
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France
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Limoges
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France
State/province [23] 0 0
Marseille
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France
State/province [24] 0 0
Paris
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France
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Rouen
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France
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Saint Herblain
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Muenchen
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Germany
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Mönchengladbach
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Germany
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Trier
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Chieti
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Italy
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Genova
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Italy
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Napoli
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Italy
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Orbassano
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Italy
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Parma
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Italy
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San Giovanni Rotondo
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Netherlands
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Amsterdam
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Peru
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Lima
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Poland
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Gliwice
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Lublin
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Poland
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Szczecin
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Poland
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Wroclaw
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Singapore
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Singapore
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South Africa
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Cape Town
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South Africa
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Pretoria
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Spain
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Alicante
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Barcelona
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Cordoba
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Elche
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Madrid
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Spain
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Santander
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Spain
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Valencia
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Sweden
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Stockholm
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Taiwan
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Kueishan
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Taiwan
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Taipei
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United Kingdom
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Glasgow
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Northwood
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United Kingdom
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Sutton
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United Kingdom
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Truro

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 are available at https://clinicaltrials.gov/study/NCT01214720