EUCTR2010-023978-39-DK进行中（未招募）不适用
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of thePancreas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 150
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
- •Disease Related
- •Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice
- •Radiologically measurable and/or non-measurable disease as defined by
- •RECIST version 1.1 Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- •Demographic
- •Men or women = 18 years of age
- •Before any protocol specified procedure is performed, the appropriate approved written informed consent must be obtained by the subject or the subject’s legally acceptable representative
- •Adequate organ function as evidenced by the following laboratory studies within 14 days before randomization:
- •Hemoglobin = 9 g/dL
- •Absolute neutrophil count = 1.5 x 109/L
- •Platelet count = 100 x 109/L (and no platelet transfusion within 14 days prior to the performance of the platelet count)
- •Partial thromboplastin (aPTT or PTT) = 1.3 x upper limit of normal (ULN) and international normalization ratio (INR) = 1.5, unless subject is on anti-coagulation therapy. Subjects on therapeutic anti-coagulation are eligible if there is no bleeding and they are on a stable dose of anticoagulation therapy (eg, warfarin with an INR of 2 to 3 within 7 days before randomization)
- •Calculated creatinine clearance = 40 mL/minute calculated by Cockcroft-Gault formula
- •Amylase = 2.0 x ULN
- •Blood glucose level = 160 mg/dL (8.9 mmol/L). Subjects with a non-fasting blood glucose > 160 mg/dL (8.9 mmol/L) must have a fasting blood glucose = 160 mg/dL (8.9 mmol/L) in order to be eligible
- •Total bilirubin = 2.0 x ULN
- •Aspartate aminotransferase (AST) and alanine amino transferase
- •(ALT) = 2.5 x ULN
- •Plan to begin protocol specified therapy within 7 days of randomization
- •Plan to be treated on protocol specified therapy until disease progression, withdrawal of consent or intolerable toxicity
- •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 127
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •Disease Related
- •Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma,
- •sarcoma, etc), adenocarcinoma originating from biliary tree or
- •cystadenocarcinoma
- •Early (stage I) or metastatic (stage IV) disease
- •External biliary drain
- •Any prior or synchronous malignancy, except:
- •Malignancy treated with curative intent and with no known active disease present for = 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Other Medical Conditions
- •Documented myocardial infarction or unstable/uncontrolled cardiac disease (eg, unstable angina, congestive heart failure [New York Heart Association(NYHA) > Class II]) within 6 months before randomization
- •History of any medical condition that in the opinion of the investigator, may increase the risks associated with study participation or protocol specified therapy or may interfere with the conduct of the study or interpretation of study results
- •Major surgical procedure within 30 days before randomization or not yet recovered from prior major surgery. Major surgery is defined within this protocol as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy)
- •Minor surgical procedures within 7 days before randomization or not yet
- •recovered from prior minor surgery; although placement of central venous access device, fine needle aspiration or endoscopic biliary stent = 1 day before randomization is acceptable
- •Known positive test for human immunodeficiency virus or hepatitis C or acute or chronic hepatitis B infection
- •Any co-morbid disease that would increase the risk of toxicity
- •Medications or Other Treatments
- •Currently treated or previously treated with biologic, small molecule,
- •immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
- •Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer
- •Recent infection requiring a course of systemic anti-infectives that was
- •completed within 7 days before randomization (with the exception of
- •uncomplicated urinary tract infection)
- •Subject is continuing to receive other investigational agent(s) or subject has not yet completed at least 30 days (before randomization) since ending other investigational device or drug study(s)
- •Subject of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding
- •Woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg diaphragm plus condom), or abstinence, during the course of protocol specified therapy and for 6 months after the last dose of protocol specified therapy for women and men (including sperm donation)
- •Subject has known sensitivity to any of the products to be administered during the study
- •Subject was previously randomized into this study
- •Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator’s knowledge
- •Subject has any kind of disorder that compromises the abi
研究者
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