A randomized, open-label, multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with cisplatin/ capecitabine chemotherapy, as first-line therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

F.Hoffmann-La Roche Ltd0 个研究点目标入组 406 人开始时间: 2012年1月27日最近更新: 2016年5月23日

试验速览

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•1. Male or female. Age = 18 years.
•2. Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least two organs (at least lung or liver or both)
•3. Measurable disease according to RECIST 1.1.
•4. HER2 positive (defined as either IHC3+ or IHC2+/ISH+, with ISH positivity defined as a ratio of >=2.0 of HER2 gene copy number/number of signals for CEP 17) primary or metastatic tumor, as assessed by central laboratory
•5. CCR >=45 ml/min
•6. ECOG PS _2
•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 263
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 142

•1. Previous chemotherapy for locally advanced or metastatic disease
•2. Prior gastrectomy
•3. Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
•4. Residual relevant toxicity resulting from previous therapy
•5. History of documented congestive heart failure; angina pectoris requiring medication; electrocardiogram (ECG) evidence of trans-mural myocardial infarction; poorly controlled hypertension (systolic blood pressure (BP) > 180 mmHg or diastolic BP>100 mm Hg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias
•6. Baseline LVEF< 50%, documented by echocardiography, MUGA scan, or cardiac MRI.

发起方