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OpenTrials
Completed

NCT Number: NCT01395017

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dasatinib

Drug

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

Drug

Matching Placebo

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

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

Acronym: LAPC

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Jul 15, 2011
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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