Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
LAPC
Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
1 other identifier
interventional
202
14 countries
73
Brief Summary
The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started Jun 2011
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 8, 2011
CompletedFirst Posted
Study publicly available on registry
July 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
March 17, 2015
CompletedApril 8, 2016
March 1, 2016
2.3 years
July 8, 2011
October 24, 2014
March 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.
From randomization until date of death from any cause by 02 December 2013
Secondary Outcomes (1)
Progression Free Survival (PFS)
Time from randomization to earliest PFS event by 02 December 2013
Study Arms (2)
Group 1
ACTIVE COMPARATOROne 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).
Group 2
PLACEBO COMPARATORThe 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologic or cytologic documentation of unresectable adenocarcinoma of the pancreas.
- Recovery from toxicity of previous procedures to establish the diagnosis. ECOG PS 0 or 1.
- Adequate organ function.
You may not qualify if:
- Evidence of metastatic disease.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Unknown Facility
Birmingham, Alabama, 35249, United States
Unknown Facility
Los Angeles, California, 90095, United States
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Orange, California, 92868, United States
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San Francisco, California, 94115, United States
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Aurora, Colorado, 80045, United States
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Boynton Beach, Florida, 33426, United States
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Tampa, Florida, 33606, United States
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Wichita, Kansas, 67214, United States
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Minneapolis, Minnesota, 55455, United States
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Albuquerque, New Mexico, 87131, United States
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Bethlehem, Pennsylvania, 18015, United States
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Blacktown, New South Wales, 2148, Australia
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Liverpool, New South Wales, 2170, Australia
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Tweed Heads, New South Wales, 2485, Australia
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Footscray, Victoria, 3011, Australia
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Frankston, Victoria, 3199, Australia
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Parkville, Victoria, 3050, Australia
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Vienna, 1090, Austria
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 3J4, Canada
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Olomouc, 77520, Czechia
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Pardubice, 532 03, Czechia
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Prague, 180 81, Czechia
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Zlín, 76275, Czechia
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Clermont-Ferrand, Auvergne, 63003, France
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Paris, Cedex 14, 75674, France
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Angers, Maine-et-Loire, 49933, France
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Saint-Priest-en-Jarez, Pays de la Loire Region, 42271, France
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Besançon, 25030, France
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Clichy, 92110, France
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Lille, 59037, France
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Lyon, 69437, France
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Saint-Priest-en-Jarez, 42277, France
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Tübingen, Baden-Wurttemberg, 72076, Germany
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Cologne, 50937, Germany
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Hamburg, 20249, Germany
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München, 81925, Germany
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Pécs, Baranya, 7624, Hungary
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Budapest, 1097, Hungary
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Budapest, 1122, Hungary
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Győr, 9024, Hungary
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Dublin, Ireland
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Milan, MI, 20133, Italy
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Udine, UD, 33100, Italy
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Ancona, 60020, Italy
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Reggio Emilia, 42100, Italy
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Jelenia Góra, 58-506, Poland
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Lublin, 20-090, Poland
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Olsztyn, 10-228, Poland
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Bucharest, Bucharest, 022328, Romania
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Craiova, Dolj, 200385, Romania
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Cluj-Napoca, 400015, Romania
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Kazan', Tatarstan Republic, 420029, Russia
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Chelyabinsk, 454087, Russia
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Krasnodar, 350040, Russia
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Moscow, 115478, Russia
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Voronezh, 394000, Russia
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Hull, East Yorks, HU16 5JQ, United Kingdom
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Chelmsford, Essex, CM1 7ET, United Kingdom
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Maidstone, Kent, ME16 9QQ, United Kingdom
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Northwood, Middlesex, HA6 2RN, United Kingdom
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Sutton, Surrey, SM2 5PT, United Kingdom
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Leeds, West Yorkshire, LS9 7TF, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Glasgow, G12 OYN, United Kingdom
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Liverpool, L69 3GA, United Kingdom
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London, SW3 6JJ, United Kingdom
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London, W12 0HS, United Kingdom
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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Unknown Facility
Salisbury, SP2 8BJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
5 participants (who had not experienced disease progression at the time of event-driven data cut-off) were told the study results and were instructed to indicate "sponsor discontinued study" if they did not want to continue in the study.
Results Point of Contact
- Title
- Global Medical Affairs
- Organization
- Otsuka Pharmaceutical Development and Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2011
First Posted
July 15, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2013
Study Completion
March 1, 2015
Last Updated
April 8, 2016
Results First Posted
March 17, 2015
Record last verified: 2016-03