A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane® plus Placebo versus Gemcitabine, Abraxane® plus 1 or 2 Truncated Courses of Demcizumab in Subjects with 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma - Yosemite

OncoMed Pharmaceuticals, Inc.0 个研究点目标入组 204 人开始时间: 2015年1月26日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

OncoMed Pharmaceuticals, Inc.