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

March 10, 2016 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
      • Liverpool, New South Wales, Australia, 2170
      • Tweed Heads, New South Wales, Australia, 2485
    • 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, M5G 2M9
      • Toronto, Ontario, Canada, M4N 3M5
    • 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
      • Besançon cedex, France, 25030
      • Clichy, France, 92110
      • Lille, France, 59037
      • Lyon cedex 03, France, 69437
      • Saint-Priest-en-Jarez cedex 2, France, 42277
    • Auvergne
      • Clermont Ferrand cedex 1, Auvergne, France, 63003
    • Cedex 14
      • Paris, Cedex 14, France, 75674
    • Loire
      • Saint-Priest-en-Jarez, Loire, France, 42271
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
  • Germany
      • Hamburg, Germany, 20249
      • Köln, Germany, 50937
      • München, Germany, 81925
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
  • Hungary
      • Budapest, Hungary, 1122
      • Budapest, Hungary, 1097
      • Gyor, Hungary, 9024
    • Baranya
      • Pecs, Baranya, Hungary, 7624
  • Ireland
      • Dublin 24, Ireland
      • Dublin 4, Ireland
      • Dublin 7, Ireland
      • Dublin 9, Ireland
  • Italy
      • Ancona, Italy, 60020
      • Reggio Emilia, Italy, 42100
    • MI
      • Milan, MI, Italy, 20133
    • UD
      • Udine, UD, Italy, 33100
  • Poland
      • Jelenia Gora, Poland, 58-506
      • Lublin, Poland, 20-090
      • Olsztyn, Poland, 10-228
  • Romania
      • Bucharest, Romania, 022328
      • Cluj-Napoca, Romania, 400015
    • Dolj
      • Craiova, Dolj, Romania, 200385
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
      • Krasnodar, Russian Federation, 350040
      • Moscow, Russian Federation, 115478
      • Voronezh, Russian Federation, 394000
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Russian Federation, 420029
  • United Kingdom
      • 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
    • East Yorks
      • Hull, East Yorks, United Kingdom, HU16 5JQ
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
    • California
      • Los Angeles, California, United States, 90095
      • Orange, California, United States, 92868
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Boynton Beach, Florida, United States, 33426
      • Tampa, Florida, United States, 33606
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization until date of death from any cause by 02 December 2013

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time from randomization to earliest PFS event by 02 December 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 287-11-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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