Locally-advanced Pancreatic Adenocarcinoma
Conditions
Interventions
Trade Name: Sprycel
Pharmaceutical Form: Film-coated tablet
Other descriptive name: DASATINIB MONOHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Other
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to compare overall survival (OS) of subjects with locallyadvanced pancreatic cancer (LAPC) who are randomized to receive dasatinib added to standard of care (gemcitabine [GEM]) versus standard of care (GEM) plus placebo;Secondary Objective: The secondary objective: • To compare progression-free survival (PFS) in subjects receiving dasatinib added to standard of care (GEM) versus standard of care (GEM) plus placebo • To compare safety in subjects receiving dasatinib added to standard of care (GEM) versus standard of care (GEM) plus placebo;Primary end point(s): • Overall survival: The primary objective of this trial is to compare OS of subjects receiving standard of care treatment (GEM) plus dasatinib versus GEM plus placebo. Subjects will be followed after discontinuation of study therapy to record time to death. The final analysis will be conducted after 135 subject deaths.;Timepoint(s) of evaluation of this end point: The final analysis will be conducted after 135 subject deaths. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression Free Survival: 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, ECOG PS, and/or CA19-9 are not by themselves considered evidence of disease progression but may be considered in the investigator’s evaluation of disease. • Safety: All AEs will be recorded with onset date, resolution or stabilization date, severity grade, and relatedness to study treatment.;Timepoint(s) of evaluation of this end point: Progression Free Survival: every 2 cycles | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Ireland, Italy, Poland, Romania, Russian Federation, South Africa, United Kingdom, United States
Contacts
Public ContactKonstantin Stoitchkov
Covance CAPS
Outcome results
None listed