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

• Conditions: ocally-advanced Pancreatic Adenocarcinoma; MedDRA version: 14.0Level: HLTClassification code 10033633Term: Pancreatic neoplasms malignant (excl islet cell and carcinoid)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024595-26-IT
• Lead Sponsor: OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-05
• Last Update Posted: 28 December 2015

Recruitment & Eligibility

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

Inclusion Criteria

1.Male and female subjects = 18 years of age.
2.Histologic or cytologic documentation of adenocarcinoma of the pancreas.
3.Unresectable disease due to local extension or invasion, for example:
?Tumor extension precluding resection, eg, mesenteric or retroperitoneal structures, vascular encasement, etc, or
?Lymph node involvement beyond the surgical field.
4.Recovery from toxicity of previous procedures that establishes diagnosis of locally advanced disease (patients with previous pancreatic resection are excluded)
5.ECOG PS 0 or 1
6.Adequate organ function:
- Absolute neutrophil count = 1,500/µL
- Platelets = 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:
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

1.Evidence of metastatic disease based on symptoms, laboratory values, or imaging studies = 21 days prior to the first dose of IMP
2.Previous radiotherapy or chemoradiotherapy
3.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
4.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
5.Clinically significant bleeding disorder or coagulopathy (eg, von Willebrand’s disease)
6.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