A Study Comparing Standard Chemotherapy to Standard Chemotherapy plus a Monoclonal Antibody (demcizumab) in Patients with Pancreatic Cancer
- Conditions
- Metastatic Pancreatic Ductal AdenocarcinomaMedDRA version: 18.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003355-56-GB
- Lead Sponsor
- OncoMed Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 204
1. Subjects must have cytologically or 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
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) <50%
• Peak tricuspid velocity >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>•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.<br>•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 Outcome Measures
Name Time Method