Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
NCT ID: NCT01395017
Last Updated: 2016-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
202 participants
INTERVENTIONAL
2011-06-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1
One arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus dasatinib 100 mg by mouth once daily (QD).
dasatinib
GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Group 2
The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).
Placebo
Matching Placebo
Interventions
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dasatinib
GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Placebo
Matching Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Recovery from toxicity of previous procedures to establish the diagnosis. ECOG PS 0 or 1.
* Adequate organ function.
Exclusion Criteria
* Previous radiotherapy or chemoradiotherapy.
* History of or current pleural effusion.
* History of significant cardiovascular disease.
* Clinically significant bleeding disorder or coagulopathy.
* Concomitant medication with strong CYP 3A4 inhibitor.
18 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Boynton Beach, Florida, United States
Tampa, Florida, United States
Wichita, Kansas, United States
Minneapolis, Minnesota, United States
Albuquerque, New Mexico, United States
Bethlehem, Pennsylvania, United States
Blacktown, New South Wales, Australia
Liverpool, New South Wales, Australia
Tweed Heads, New South Wales, Australia
Footscray, Victoria, Australia
Frankston, Victoria, Australia
Parkville, Victoria, Australia
Vienna, , Austria
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Olomouc, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Zlín, , Czechia
Clermont-Ferrand, Auvergne, France
Paris, Cedex 14, France
Angers, Maine-et-Loire, France
Saint-Priest-en-Jarez, Pays de la Loire Region, France
Besançon, , France
Clichy, , France
Lille, , France
Lyon, , France
Saint-Priest-en-Jarez, , France
Tübingen, Baden-Wurttemberg, Germany
Cologne, , Germany
Hamburg, , Germany
München, , Germany
Pécs, Baranya, Hungary
Budapest, , Hungary
Budapest, , Hungary
Győr, , Hungary
Dublin, , Ireland
Milan, MI, Italy
Udine, UD, Italy
Ancona, , Italy
Reggio Emilia, , Italy
Jelenia Góra, , Poland
Lublin, , Poland
Olsztyn, , Poland
Bucharest, Bucharest, Romania
Craiova, Dolj, Romania
Cluj-Napoca, , Romania
Kazan', Tatarstan Republic, Russia
Chelyabinsk, , Russia
Krasnodar, , Russia
Moscow, , Russia
Voronezh, , Russia
Hull, East Yorks, United Kingdom
Chelmsford, Essex, United Kingdom
Maidstone, Kent, United Kingdom
Northwood, Middlesex, United Kingdom
Sutton, Surrey, United Kingdom
Leeds, West Yorkshire, United Kingdom
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Salisbury, , United Kingdom
Countries
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Other Identifiers
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287-11-201
Identifier Type: -
Identifier Source: org_study_id
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