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

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.
ClinicalTrials.gov Identifier: NCT01395017
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : March 17, 2015
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

July 8, 2011
July 15, 2011
October 24, 2014
March 17, 2015
April 8, 2016
June 2011
October 2013   (Final data collection date for primary outcome measure)
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.
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. ]
Complete list of historical versions of study NCT01395017 on ClinicalTrials.gov Archive Site
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.
Progression Free Survival (PFS) [ Time Frame: Subjects will be assessed by imaging after every 2 cycles (ie, Weeks 8, 16, 24, etc.). ]
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.
Not Provided
Not Provided
 
Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pancreatic Cancer
  • 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
  • Drug: Placebo
    Matching Placebo
  • 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).
    Intervention: Drug: dasatinib
  • 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).
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
200
March 2015
October 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Ireland,   Italy,   Poland,   Romania,   Russian Federation,   United Kingdom,   United States
 
 
NCT01395017
287-11-201
Yes
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP