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Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer (LAPC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395017
First Posted: July 15, 2011
Last Update Posted: April 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer Drug: dasatinib Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization until date of death from any cause by 02 December 2013 ]
    Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Time from randomization to earliest PFS event by 02 December 2013 ]
    PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.


Enrollment: 202
Study Start Date: June 2011
Study Completion Date: March 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Drug: 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.
Other Name: BMS-354825
Placebo Comparator: 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).
Drug: Placebo
Matching Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395017


  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35249
United States, California
Los Angeles, California, United States, 90095
Orange, California, United States, 92868
San Francisco, California, United States, 94115
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Boynton Beach, Florida, United States, 33426
Tampa, Florida, United States, 33606
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18015
Australia, New South Wales
Blacktown, New South Wales, Australia, 2148
Liverpool, New South Wales, Australia, 2170
Tweed Heads, New South Wales, Australia, 2485
Australia, Victoria
Footscray, Victoria, Australia, 3011
Frankston, Victoria, Australia, 3199
Parkville, Victoria, Australia, 3050
Austria
Wien, Austria, 1090
Belgium
Brussels, Belgium, 1200
Gent, Belgium, 9000
Leuven, Belgium, 3000
Canada, Ontario
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H2X 3J4
Czech Republic
Olomouc, Czech Republic, 77520
Pardubice, Czech Republic, 532 03
Prague 8, Czech Republic, 180 81
Zlin, Czech Republic, 76275
France
Clermont Ferrand cedex 1, Auvergne, France, 63003
Paris, Cedex 14, France, 75674
Saint-Priest-en-Jarez, Loire, France, 42271
Angers, Maine-et-Loire, France, 49933
Besançon cedex, France, 25030
Clichy, France, 92110
Lille, France, 59037
Lyon cedex 03, France, 69437
Saint-Priest-en-Jarez cedex 2, France, 42277
Germany
Tübingen, Baden-Württemberg, Germany, 72076
Hamburg, Germany, 20249
Köln, Germany, 50937
München, Germany, 81925
Hungary
Pecs, Baranya, Hungary, 7624
Budapest, Hungary, 1097
Budapest, Hungary, 1122
Gyor, Hungary, 9024
Ireland
Dublin 24, Ireland
Dublin 4, Ireland
Dublin 7, Ireland
Dublin 9, Ireland
Italy
Milan, MI, Italy, 20133
Udine, UD, Italy, 33100
Ancona, Italy, 60020
Reggio Emilia, Italy, 42100
Poland
Jelenia Gora, Poland, 58-506
Lublin, Poland, 20-090
Olsztyn, Poland, 10-228
Romania
Craiova, Dolj, Romania, 200385
Bucharest, Romania, 022328
Cluj-Napoca, Romania, 400015
Russian Federation
Kazan, Tatarstan Republic, Russian Federation, 420029
Chelyabinsk, Russian Federation, 454087
Krasnodar, Russian Federation, 350040
Moscow, Russian Federation, 115478
Voronezh, Russian Federation, 394000
United Kingdom
Hull, East Yorks, United Kingdom, HU16 5JQ
Chelmsford, Essex, United Kingdom, CM1 7ET
Maidstone, Kent, United Kingdom, ME16 9QQ
Northwood, Middlesex, United Kingdom, HA6 2RN
Sutton, Surrey, United Kingdom, SM2 5PT
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Edinburgh, United Kingdom, EH4 2XU
Glasgow, United Kingdom, G12 OYN
Liverpool, United Kingdom, L69 3GA
London, United Kingdom, SW3 6JJ
London, United Kingdom, W12 0HS
Salisbury, United Kingdom, SP2 8BJ
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01395017     History of Changes
Other Study ID Numbers: 287-11-201
First Submitted: July 8, 2011
First Posted: July 15, 2011
Results First Submitted: October 24, 2014
Results First Posted: March 17, 2015
Last Update Posted: April 8, 2016
Last Verified: March 2016

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Pancreatic cancer
Dasatinib
chemotherapy
Locally advanced

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Dasatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors