A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer

NCT ID: NCT01214720

Last Updated: 2014-08-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

607 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-10-31

Brief Summary

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This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

Intervenous repeating dose

Interventions

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bevacizumab [Avastin]

Intervenous repeating dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* metastatic pancreatic cancer (adenocarcinoma);
* good liver, kidney, and bone marrow function.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Adelaide, , Australia

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Camperdown, , Australia

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Footscray, , Australia

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Heidelberg, , Australia

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Kurralta Park, , Australia

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Melbourne, , Australia

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Melbourne, , Australia

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St Leonards, , Australia

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Sydney, , Australia

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Sydney, , Australia

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Graz, , Austria

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Innsbruck, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Antwerp, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Wilrijk, , Belgium

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Beijing, , China

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Beijing, , China

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Shanghai, , China

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Brno, , Czechia

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Hradec Králové, , Czechia

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Helsinki, , Finland

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Besançon, , France

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Bordeaux, , France

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Boulogne-Billancourt, , France

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Clichy, , France

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Limoges, , France

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Marseille, , France

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Paris, , France

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Paris, , France

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Rouen, , France

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Saint-Herblain, , France

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Strasbourg, , France

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Berlin, , Germany

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Bochum, , Germany

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Bonn, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Leipzig, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Mönchengladbach, , Germany

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München, , Germany

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Trier, , Germany

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Kfar Saba, , Israel

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Petah Tikva, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Bergamo, , Italy

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Bologna, , Italy

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Brescia, , Italy

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Chieti, , Italy

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Genova, , Italy

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Napoli, , Italy

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Orbassano, , Italy

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Parma, , Italy

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San Giovanni Rotondo, , Italy

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Amsterdam, , Netherlands

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Lima, , Peru

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Lima, , Peru

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Gliwice, , Poland

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Lublin, , Poland

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Szczecin, , Poland

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Wroclaw, , Poland

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Singapore, , Singapore

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Singapore, , Singapore

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Cape Town, , South Africa

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Pretoria, , South Africa

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Alicante, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Córdoba, , Spain

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Elche, , Spain

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Madrid, , Spain

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Santander, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Stockholm, , Sweden

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Kueishan, , Taiwan

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Taipei, , Taiwan

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Glasgow, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Northwood, , United Kingdom

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Sutton, , United Kingdom

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Truro, , United Kingdom

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Countries

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Australia Austria Belgium Canada China Czechia Finland France Germany Israel Italy Netherlands New Zealand Peru Poland Singapore South Africa Spain Sweden Taiwan United Kingdom

Other Identifiers

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BO17706

Identifier Type: -

Identifier Source: org_study_id

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