EUCTR2011-004923-11-HU进行中（未招募）不适用
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) with Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
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
- Amgen Inc
- 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
- •Inclusion Criteria
- •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 required
- •Evaluable (measurable or non-measurable) disease by RECIST 1.1 criteria
- •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:
- •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
- •Exclusion Criteria
- •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 (ECHO)
- •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 investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study resultsMajor surgical procedure = 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 surgery (eg, catheter or gastrostomy tube placement) =14 days before randomization or not yet recovered from prior minor surgery. Placement of central venous access device, fine needle aspiration, thoracentesis, endoscopic biliary stent or paracentesis = 1 day before randomization is acceptable
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