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11月30日最近更新: 2017年8月21日

试验速览

阶段: 1 期
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.
•Subject with prior gastrectomy (total or partial) may be allowed to participate
•in the study as long as they can take oral medications and meet all other
•inclusion/exclusion criteria. Subjects may not take crushed or dissolved
•capecitabine via a feeding/gastrostomy tube.
•Subjects who received palliative radiotherapy for the metastatic esophageal or
•gastric cancer prior to study entry may be allowed to participate in the study
•as long as all toxicities from radiotherapy have resolved and the radiotherapy
•was not to the only site of known metastatic disease.
•Measurable or non-measurable disease per modified RECIST (Response Evaluation
•Criteria in Solid Tumor) Guidelines (please refer to Appendix G). All scans and
•x-rays used to document measurable or non-measurable disease must be
•done within 28 days prior to randomization
•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 consent to the 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:
•- Absolute neutrophil count (ANC) = 1.5 x 109/L
•- Platelet count = 75 x 109/L and = 850 x 109/L
•- Hemoglobin = 9 g/dL
•Coagulation function, as follows:
•- PTT or aPTT = 1.5 x ULN per institutional laboratory normal range
•- INR = 1.5
•Renal function, as follows:
•- Urinary protein quantitative value of = 30 mg/dl in urinalysis or = 1+ on dipstick,
•unless quantitative protein is < 1000 mg in a 24 hour urine sample
•- Creatinine clearance = 50 mL/min
•Investigators may calculate creatinine clearance (CrCl) by either Cockcroft-Gault
•formula or 24 hour urine creatinine clearance.
•(140-age) x actual body weight (kg)
•CrCl (mL/min) = (x 0.85 for females)
•72 x serum creatinine (mg/dL)
•(140-age) x actual body weight (kg)
•CrCl (mL/min) = (x 0.85 for females)
•0.8136 x serum creatinine (umol/L)
•Hepatic function, as follows:
•- Total bilirubin = 1.5 x ULN
•- SGOT (AST) and SGPT (ALT) = 2.5 x ULN (= 5 x ULN if liver metastases are
•Are the trial subjects under 18? no
另有 5 项未显示

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
•Radiotherapy = 14 days prior to randomization. Subjects must have recovered
•from all radiotherapy-related toxicities
•Current or prior history of central nervous system metastases
•History of arterial or deep venous thromboembolism within 12 months prior to
•randomization
•History of clinically significant bleeding within 6 months prior to randomization
•Major surgical procedure within 28 days prior to randomization
•Minor surgical procedure, placement of central venous access device (PICC or
•peripherally inserted central catheter lines) or fine needle aspiration within 3 days
•prior to randomization
•Subjects with a history of prior malignancy, except:
•- Malignancy treated with curative intent and with no known active disease
•present for = 3 years prior to enrollment (or randomization) and felt to be at
•low risk for recurrence by treating physician
•- Adequately treated non-melanomatous 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
•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, percutaneous
•transluminal coronary angioplasty/stent
•Non-healing wound, ulcer (including gastrointestinal) or fracture
•Ongoing or clinically significant active infection as judged by the investigator
•Known hypersensitivity to bacterial proteins, or any of the drugs required in this study
•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 AMG 386, or other molecules that inhibits
•angiopoietin, or TIE-2 receptors including, but not limited to, XL-820, XL-184, or
•CVX-060/PF-4856884
•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
•Concurrent or prior (within 7 days prior to randomization) anticoagulation
•therapy, excluding aspirin and anti-platelet agents. The concurrent use of low
•molecular weight heparin or heparanoids or low dose warfarin (ie, = 1 mg daily)
•for prophylaxis against thrombosis is acceptable while on study
•Any condition which in the investigator’s opinion makes the subject unsuitable for
•study participation
另有 5 项未显示

研究者

发起方

Amgen Inc.

相似试验

进行中（未招募）

不适用

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 AdenocarcinomaMetastatic Gastric, Gastroesophageal Junction, or Distal Esophageal AdenocarcinomaMedDRA version: 9.1Level: LLTClassification code 10063916Term: Metastatic gastric cancerMedDRA version: 9.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junction

EUCTR2007-003573-50-NLAmgen Inc.165

进行中（未招募）

不适用

EUCTR2007-003573-50-HUAmgen Inc.165

进行中（未招募）

1 期

EUCTR2007-003573-50-FRAmgen Inc.165

进行中（未招募）

不适用

EUCTR2007-003573-50-ATAmgen Inc.165

进行中（未招募）

1 期

Phase 2 Study of AMG 386 (20060439) in Combination With Cisplatin & Capecitabine in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal AdenocarcinomaMetastatic Gastric, Gastroesophageal Junction, or Distal Esophageal AdenocarcinomaMedDRA version: 14.0 Level: PT Classification code 10063916 Term: Metastatic gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0 Level: LLT Classification code 10066354 Term: Adenocarcinoma of the gastroesophageal junction System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2007-003573-50-GBAmgen Inc.165