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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


  Show 77 Study Locations
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