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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01395017
First received: July 8, 2011
Last updated: June 3, 2013
Last verified: May 2013
History of Changes
  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
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • The primary efficacy endpoint is overall survival. [ Time Frame: Participants will be followed for the duration of the study, the participants will be contacted monthly for an expected average of 12-16 months to collect survival data after study discontinution. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: Subjects will be assessed by imaging after every 2 cycles (ie, Weeks 8, 16, 24, etc.). ] [ Designated as safety issue: No ]
    Progression events will be investigator determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria. Worsening pain, fatigue, and/or CA19-9 are not by themselves considered disease progression but may be considered by the investigator in evaluation of disease. All adverse events (AEs) will be recorded by National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 grade and by causal attribution. Resolution date will be recorded for all SAEs and treatment-related AEs of Grade ≥3.


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395017

  Show 99 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01395017     History of Changes
Other Study ID Numbers: 287-11-201
Study First Received: July 8, 2011
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013