EUCTR2009-009194-99-ES进行中（未招募）不适用
A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects with Metastatic Pancreatic Cancer?Estudio global, multicéntrico, abierto, de fase II de AGS-1C4D4 administrado en combinación con gemcitabina en sujetos con cáncer de páncreas metastásico.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Agensys Inc
- 入组人数
- 185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Man or woman 18 years of age or older
- •2.Pathologically confirmed metastatic adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded
- •3.Non-measurable or measurable disease based on the RECIST criteria
- •4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •5.Life expectancy of > 3 months as documented by the investigator
- •6.Hematologic function, as follows:
- •a.Absolute neutrophil count (ANC)= 1.5 x 109/L
- •b.Platelet count = 100 x 109/L
- •c.Hemoglobin = 9 g/dL (transfusion independent)
- •7.Renal function, as follows:
- •a.Creatinine =2.0 mg/dL
- •8. Hepatic function, as follows:
- •a.Aspartate aminotransferase (AST) = 2.5 x ULN or = 5 x ULN if known liver metastases.
- •b.Alanine aminotransferase (ALT) = 2.5 x ULN
- •c.Bilirubin =2 x ULN
- •9. INR <1.3 (or 3 if on warfarin for therapeutic anti-coagulation)
- •10. Competent to comprehend, sign, and date an independent ethics committee/institutional review board (IEC/IRB) approved informed consent form.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior systemic therapy for metastatic pancreatic cancer (prior systemic treatment for local disease is allowed)
- •2.Chemotherapy and/or radiation within 4 weeks of study enrollment
- •3.Prior monoclonal antibody therapy within 60 days of study enrollment
- •4.Brain or leptomeningeal disease
- •5.History of other primary malignancy, unless:
- •a.Curatively resected non-melanomatous skin cancer
- •b.Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
- •6.Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System)
- •7.Use of any investigational product within 4 weeks of study enrollment
- •8.Major surgery (that requires general anesthesia) within 4 weeks before study enrollment
- •9.Women who are pregnant (confirmed by positive pregnancy test) or lactating
- •10.Man or woman of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for 4 weeks after the last AGS-1C4D4 and/or gemcitabine infusion administration
- •11.Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive
- •12.Active serious infection not controlled with antibiotics
- •13.Subject unwilling or unable to comply with study requirements
- •14.Known allergy to the ingredients of the study drug or to Staphylococcus protein A
- •15.Any medical or psychiatric disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
研究者
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