Study for people with locally advanced pancreatic cancer (inoperable but without distant spread) of gemcitabine chemotherapy plus either dasatinib or placebo

• Conditions: ocally-advanced Pancreatic Adenocarcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024595-26-CZ
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-07
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion Criteria
• Histologic or cytologic documentation of adenocarcinoma of the pancreas
• Unresectable disease due to local extension or invasion, for example:
- Tumor extension precluding resection, eg, to
mesenteric or retroperitoneal structures,vascular
encasement, etc, or
- Lymph node involvement beyond the surgical field
• Recovery from toxicity of previous procedures that establish diagnosis of locally-advanced disease (patients with previous pancreatic resection are excluded)
• ECOG PS 0 or 1
• Adequate organ function:
- Absolute neutrophil count = 1,500/µL
- Platelet count = 100,000/µL
- Bilirubin = 2.0 X upper limit of normal (ULN)
- Creatinine = 1.5 mg/dL
- Aspartate transaminase = 2.5 X ULN
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Exclusion Criteria
• Evidence of metastatic disease based on symptoms, laboratory values, or imaging studies = 21 days prior to the first dose of IMP
• Previous radiotherapy or chemoradiotherapy
• History of or current pleural effusion (any cause, = Grade 1) within 6 months prior to the first dose of IMP.
An equivocal finding at the costophrenic angle is allowed
• History of significant cardiovascular disease or the
following events within 6 months prior to the first dose of IMP: coronary infarction, life-threatening arrhythmia, or QTc prolongation > 470 ms
• Clinically significant bleeding disorder or coagulopathy (eg, von Willebrand’s disease)
• Requirement for a concomitant medication that is a strong inhibitor of Cytochrome P450 (CYP) 3A4

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified