Metastatic Pancreatic Ductal Adenocarcinoma MedDRA version: 18.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Sponsors
OncoMed Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed. 2. Age >=21 years 3. ECOG performance status 0 or 1 4. Measurable disease per RECIST v1.1 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 121
Exclusion criteria
Exclusion criteria: 1. Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies. 2. Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents. 3. Any of the following cardiac-related criteria: -B-type natriuretic peptide (BNP) value of >100 pg/mL -Left ventricular ejection fraction (LVEF) 3.0 m/s on Doppler echocardiogram -Receiving any medications for cardiac ischemia -Current evidence of cardiac ischemia -History of acute myocardial infarction within 6 months prior to randomization -New York Heart Association Classification II, III, or IV. For subjects to meet class II criteria with mild shortness of breath and/or angina, as defined by the NYHA guidelines, the cardiac etiology of the symptoms should be confirmed by a cardiologist taking 12-lead electrocardiogram, transthoracic Doppler echocardiogram and other studies into consideration, as appropriate. -History of heart failure or pulmonary hypertension -Received a total cumulative dose of >= 400 mg/m2 doxorubicin -Grade >=2 ventricular arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma;Secondary Objective: To compare the safety of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. To compare the rate of immunogenicity of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. To determine population pharmacokinetics of demcizumab in subjects receiving demcizumab, Abraxane® and gemcitabine in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma.;Primary end point(s): To compare the hazard of progression using the Investigator assessed progression-free survival time between subjects in Arm 1 and Arm 2 as well as between subjects in Arm 1 and 3 in 1st-line metastatic pancreatic ductaladenocarcinoma.;Timepoint(s) of evaluation of this end point: At scheduled visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -To compare the Investigator-assessed RECIST response rate in Arm 1 to Arm 2 and Arm 1 to 3 in subjects with 1st-line metastatic pancreatic cancer. -To compare the Investigator-assessed RECIST clinical benefit rate (i.e., the rate of complete response + partial response + stable disease) in Arm 1 to Arm 2 and Arm 1 to 3 in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. -To compare the Investigator-assessed progression-free survival at 6 months in Arm 1 to Arm 2 and Arm 1 to 3 in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. -To compare the Independent Review Facility (IRF)-assessed RECIST response rate and progression-free survival based solely on radiographs in Arm 1 to Arm 2 and Arm 1 to 3 (Optional). -To determine the half-life, volume of distribution and clearance of demcizumab when combined with Abraxane® and gemcitabine in with subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. -To compare the safety profile through adverse event monitoring (including attribution of adverse events and serious adverse events [SAEs]), physical examination, vital signs, and clinical laboratory testing as outlined in the Schedule of Assessments between Arm 1 to Arm 2 and Arm 1 to 3 in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. To compare the incidence of anti-demcizumab antibody development and neutralizing antibody development in subjects with 1st-line locally advanced or metastatic pancreatic ductal adenocarcinoma being treated with Abraxane® and gemcitabine plus demcizumab in Arm 1 to Arm 2 and Arm 1 to 3. -To compare the median survival in Arm 1 to Arm 2 and Arm 1 to 3 in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma -To compare the Kaplan Meier estimates of survival at 6, 12, 18 and 24 months in Arm 1 to Arm 2 and Arm 1 to 3 in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma.;Timepoint(s) of evaluation of this end poin | — |
Countries
Australia, Belgium, Canada, Spain, United Kingdom, United States
Contacts
Public ContactVP, Clinical Research
OncoMed Pharmaceuticals, Inc.
Outcome results
None listed