EUCTR2011-004923-11-IT进行中（未招募）不适用
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo ControlledStudy of Rilotumumab (AMG 102) with Epirubicin, Cisplatin, andCapecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
AMGEN INC.0 个研究点目标入组 450 人开始时间: 2012年12月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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
- •Pathologically confirmed unresectable locally advanced or metastatic
- •gastric or GEJ adenocarcinoma; adenocarcinomas of the distal
- •esophagus within 5 cm of the GEJ are eligible
- •ECOG performance status (0 or 1)
- •Tumor MET-positive by IHC (fulfilling the MET IHC criteria as defined
- •by an investigational use only MET IHC assay) by protocol-specified
- •centralized testing
- •Formalin fixed paraffin-embedded (FFPE) tumor tissue submission
- •Evaluable (measurable or non-measurable) disease by RECIST 1.1
- •Demographic
- •Men or women = 18 years of age
- •Before any study-specific procedure, the appropriate written
- •informed consent must be obtained (Section 11.1)
- •Adequate organ function as evidenced by the following laboratory
- •studies within 28 days prior to randomization:
- •- Hemoglobin = 9 g/dL
- •- Absolute neutrophil count = 1.5 x 109/L
- •- Platelet count = 100 x 109/L
- •- Creatinine clearance = 60mL/minute (calculated or measured)
- •- Aspartate aminotransferase (AST) and alanine amino transferase (ALT)
- •= 2.5 x ULN or AST and ALT = 5.0 x ULN if liver metastases are present
- •- Total bilirubin = 1.5x ULN
- •Able to tolerate infusions and take oral medications
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 290
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Disease Related
- •HER2-overexpressing locally advanced or metastatic gastric or GEJ
- •adenocarcinoma. Subjects whose tumor HER2 expression status is not
- •known must submit tumor samples for HER2 testing
- •Previous systemic therapy (including chemotherapy, biologic,
- •immunotherapy, or investigational therapy) for locally advanced or
- •metastatic gastric or GEJ or lower esophageal (within 5 cm of GEJ)
- •adenocarcinoma Less than 6 months have elapsed from completion of
- •prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to
- •randomization
- •Previous treatment with anthracyclines exceeds total cumulative dose
- •of epirubicin of 400 mg/m2 (or equivalent thereof, if a different
- •anthracycline has been administered in the past)
- •Subjects with ongoing toxicities from palliative radiotherapy, or who
- •have undergone radiotherapy to the only site of known disease, or
- •received palliative radiation = 14 days prior to randomization. Subjects
- •who received palliative
- •radiotherapy are otherwise eligible.
- •Squamous cell histology
- •Subjects with resectable disease or suitable for definitive
- •chemoradiation
- •Plans for surgical resection or definitive chemoradiation based on
- •response to protocol therapy
- •Subjects who have persistent gastric outlet obstruction, complete
- •dysphagia or are dependent upon jejunostomy for feeding
- •Known central nervous system metastases
- •Clinically significant upper gastro-intestinal bleeding < 30 days prior to
- •randomization
- •Other Medical Conditions
- •Left ventricular ejection fraction (LVEF) < 50% as determined by
- •either multiple gated acquisition (MUGA) scan or echocardiogram
- •Documented myocardial infarction or unstable/uncontrolled cardiac
- •disease (eg, unstable angina, severe arrhythmias, congestive heart
- •failure [New York Heart Association (NYHA) > Class II]) within 6 months
- •before randomization (Appendix E)
- •Presence of peripheral edema > grade 1
- •Arterial thrombosis or vascular ischemic events, such as transient
- •ischemic attack, cerebral infarction, within six months prior to
- •randomization
- •Subjects with venous thromboembolic events (including deep vein
- •thrombosis or pulmonary emboli) within 6 months prior to
- •randomization
- •Serious or non-healing wound
- •Known positive HepBsAg (indicative of acute or chronic Hepatitis B) or
- •detectable Hepatitis C virus (indicative of active Hepatitis C), known
- •positive test for HIV
- •Known peripheral neuropathy > grade 1
- •Known dihydropyrimidine dehydrogenase deficiency (DPD)
- •History of any medical condition including cardiovascular disease or
- •chronic obstructive pulmonary disease (COPD), that in the opinion of the
- 另有 12 项未显示
研究者
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