A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination with AMG 386 or Placebo in Subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma

Amgen Inc.0 个研究点目标入组 165 人开始时间: 2007年10月26日最近更新: 2012年9月18日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 165

研究概览入排标准研究者记录与标识符相似试验

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
•Histologically or cytologically confirmed adenocarcinoma of the stomach,
•gastroesophageal junction or distal esophagus with metastatic disease.
•All scans and x-rays used to document measurable or non-measurable
•disease must be done within 28 days prior to randomization
•Measurable or non-measurable disease per modified RECIST (Response
•Evaluation Criteria in Solid Tumor) Guidelines
•Demographic
•18 years of age or older at the time the written informed consent is obtained
•Subjects of child-bearing potential and sexually active must use an accepted and
•effective non-hormonal method of contraception (ie, double barrier method
•[eg, condom plus diaphragm]) from signing the informed consent through
•6 months following last administration of study drug
•Able to tolerate intravenous infusions
•Able to swallow oral medication
•ECOG performance status of 0 or 1 (within 14 days prior to randomization)
•Subject plans to begin protocol directed therapy within 7 days of randomization
•Adequate organ and hematological function as evidenced by the following laboratory
•studies within 14 days prior to randomization:
•Hematological function, as follows:
•o Absolute neutrophil count (ANC) = 1.5 x 109/L
•o Platelet count = 75 x 109/L and = 850 x 109/L
•o Hemoglobin = 9 g/dL
•o PTT and INR = ULN
•Renal function, as follows:
•o Creatinine clearance = 60 mL/min
•- Investigators may calculate creatinine clearance by either
•Cockcroft-Gault formula or 24 hour urine creatinine clearance.
•Creatinine clearance (mL/min) = (140–age) x actual body weight (kg) (x 0.85 for females)
•72 x serum creatinine (mg/dL)
•Hepatic function, as follows:
•o Total bilirubin = 1.5 x ULN
•o SGOT (AST) and SGPT (ALT) = 2.5 x ULN (= 5 x ULN if liver metastases are
•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

•Disease Related
•Prior chemotherapy for metastatic disease (1st line)
•Less than 12 months have elapsed from completion of previous adjuvant or
•neoadjuvant chemotherapy or chemoradiotherapy
•Subjects with persistant gastric outlet obstruction, complete dysphagia or feeding
•jejunostomy
•Current or prior history of central nervous system metastases
•History of bleeding diathesis or clinically significant bleeding within 14 days prior
•to randomization
•Major surgical procedure within 28 days prior to randomization
•Minor surgical procedure, placement of access device, or fine needle aspiration
•within 7 days prior to first dose
•Prior malignancy (other than in situ cervical cancer, or basal cell cancer of the
•skin) unless treated with curative intent and without evidence of disease for = 3
•years prior to randomization
•Clinically significant cardiovascular diseases within 12 months prior to
•randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication
•Presence of clinically significant non-healing wound, ulcer or fracture as judged
•by the investigator
•Ongoing or clinically significant active infection as judged by the investigator
•Known hypersensitivity to bacterial proteins, or any of the drugs required in this
•Known peripheral neuropathy = Grade 1
•Known dihydropyrimidine dehydrogenase deficiency
•Known hypersensitivity to 5-FU/capecitabine
•Known positive test for human immunodeficiency virus (HIV), hepatitis C, or
•hepatitis B surface antigen
•Known active or chronic hepatitis
•Medications
•Currently or previously treated with angiopoietin inhibitors, or inhibitors of TIE-1
•or TIE-2 including, but not limited to, AMG 386, XL880, XL820
•Treatment with immune modulators such as cyclosporine or tacrolimus within
•30 days prior to randomization
•Treatment with sorivudine or its chemically related analogues such as brivudine
•Anticoagulants (other than aspirin) including *coumarin-type anticoagulants
•(other than low dose prophylaxis for central venous catheters = 1mg/day) or
•heparin (except for low molecular weight heparin for prophylaxis against central
•venous catheter thrombosis) within 7 days prior to randomization
•* Coumarin-type anticoagulants may be used in subjects receiving
•capecitabine with an increased frequency of INR and PTT monitoring.
•Any condition which in the investigator’s opinion makes the subject unsuitable for
•study participation
•Not yet completed at least 30 days since ending other investigational device/drug
•trial(s), or subject is receiving other investigational treatments
•Pregnant (ie, positive beta-human chorionic gonadotropin test) or is breast feeding
•Previously enrolled into this study
•Inability to comply with protocol and/or not available for follow-up assessments

研究者

发起方

Amgen Inc.

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