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临床试验/EUCTR2012-001402-23-CZ
EUCTR2012-001402-23-CZ进行中（未招募）1 期

A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB (MetMAb) IN COMBINATION WITH 5-FLUOROURACIL, FOLINIC ACID, AND OXALIPLATIN (mFOLFOX6) IN PATIENTS WITH METASTATIC HER2-NEGATIVE,MET-POSITIVE GASTROESOPHAGEAL CANCER

F. Hoffmann-La Roche Ltd.0 个研究点目标入组 800 人开始时间: 2012年8月14日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
800
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

  • •Male or female, 18 years of age or older
  • •ECOG performance status of 0 or 1
  • •Life expectancy > 3 months
  • •Histologically confirmed adenocarcinoma of the stomach or GEJ with inoperable metastatic disease not amenable to curative therapy
  • •Adequate archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tissue for central IHC assay of Met receptor and HER2 status
  • •Tumor (either primary or metastatic lesion) defined as Met positive by IHC (= 50% of tumor cells with membrane and/or cytoplasmic staining at weak, moderate, or high intensity)
  • •Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  • •Patients with peritoneal disease would generally be regarded as having evaluable disease and be allowed to enter the trial.
  • •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 600
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 200

排除标准

  • •HER2-positive tumor (primary tumor or metastasis)
  • •HER2-positivity is defined as either IHC 3+ or IHC 2+/ISH+; ISH positivity is defined as a HER2:CEP17 ratio of = 2.0.
  • •Previous chemotherapy for locally advanced or metastatic gastric carcinoma Patients may have received either neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to randomization.
  • •Prior exposure to experimental treatment targeting either the HGF or Met pathway
  • •History of another malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, localized prostate cancer that has been treated surgically with curative intent and presumed cured, or other malignancies with an expected curative outcome
  • •Hematologic, Biochemical, and Organ Function
  • •Granulocyte count < 1500/mm3, platelet count < 100,000/mm3, and hemoglobin < 9.0 g/dL within 7 days prior to enrollment
  • •Partial thromboplastin time (PTT), international normalized ratio (INR), or prothrombin time (PT) > 1.5 x the upper limit of normal (ULN), except for patients receiving anticoagulation therapy
  • •AST (SGOT), ALT (SGPT), alkaline phosphatase (ALP) = 2.5 × ULN (= 5 × ULN with liver metastases)
  • •Total bilirubin = 1.5 × ULN (except in patients diagnosed with Gilbert’s disease)
  • •Serum calcium > ULN (corrected for low serum albumin concentrations) Corrected calcium (mg/dL) = serum Ca2+ + [(4.0–measured serum albumin) x 0.8] Corrected calcium (mmol/L) = serum Ca2+ + 0.02 × (40–serum albumin)
  • •Serum creatinine > 1.5 × ULN or calculated creatinine clearance < 60 mL/min (Cockcroft and Gault 1976)
  • •Uncontrolled diabetes as evidenced by fasting serum glucose level > 200 mg/dL
  • •Clinically significant gastrointestinal abnormalities, apart from gastric cancer, including uncontrolled inflammatory gastrointestinal diseases (Crohn’s disease, ulcerative colitis, etc.)
  • •Known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), or known HIV-seropositivity.
  • •Major surgery within 4 weeks before start of study treatment, without complete recovery

研究者

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