EUCTR2012-001402-23-ES进行中（未招募）不适用
A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACYAND SAFETY OF ONARTUZUMAB (MetMAb) IN COMBINATIONWITH 5-FLUOROURACIL, FOLINIC ACID, AND OXALIPLATIN(mFOLFOX6) IN PATIENTS WITH METASTATIC HER2-NEGATIVE,MET-POSITIVE GASTROESOPHAGEAL CANCER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
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, 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 HIVseropositivity.
- •- Major surgery within 4 weeks before start of study treatment, without complete recovery.
研究者
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