NCT01983878已完成2 期
A Phase 2 Study of Ramucirumab in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First Line Platinum- or Fluoropyrimidine-Containing Combination Therapy in Japanese Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks)
研究概览
简要总结
The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma
- •Metastatic disease or locally recurrent, unresectable disease
- •Measurable disease and/or evaluable disease
- •Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy
- •Life expectancy of at least 3 months
- •Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse , Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
- •Eastern Cooperative Oncology Group performance status score of 0-1
- •Has adequate organ function
- •Must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods), if sexually active
- •Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment
排除标准
- •Documented and/or symptomatic brain or leptomeningeal metastases
- •Bone metastases
- •Experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment
- •Experienced any arterial thromboembolic event within 6 months prior to enrollment
- •Ongoing or active significant infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thromboembolic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator
- •Ongoing or active psychiatric illness or social situation that would limit compliance with study requirements
- •Blood pressure in abnormal range despite standard medical management
- •Has a serious or nonhealing wound, ulcer, or bone fracture
- •Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer
- •Received any investigational therapy within 30 days prior to enrollment
- •Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
- •Received prior therapy with an agent that directly inhibits vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor 2 (VEGFR-2) activity (including bevacizumab), or any anti-angiogenic agent
- •Receiving chronic therapy with nonsteroidal anti-inflammatory drugs or receiving other antiplatelet agents. Aspirin use at doses up to 325 milligrams per day is permitted
- •Has elective or planned major surgery to be performed during the course of the clinical study
- •Has a known allergy to any of the treatment components
- •Pregnant or breastfeeding
- •Have positive test results for human immunodeficiency virus, hepatitis B, or hepatitis C antibodies
- •Known alcohol or drug dependency
- •Previous or concurrent malignancy except for basal or squamous cell skin cancer (nonmelanoma) and/or pre-invasive carcinoma of the cervix, mucosal gastrointestinal or uterine carcinoma, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to enrollment
- •Currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
研究组 & 干预措施
Ramucirumab
Experimental
Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment will continue until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance or withdrawal of consent.
干预措施: Ramucirumab (Drug)
结局指标
主要结局
Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks)
时间窗: 12 Weeks
The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate.
次要结局
- Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)](Baseline to Measured PD or Death from Any Cause (Up to 12 Months))
- Overall Survival (OS)(Baseline to Death from Any Cause (Up to 13 Months))
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab(Cycle 1 Day 1: Pre-Dose, End of Infusion. 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose)
- PK: Area Under the Curve Time Zero to Infinity (AUC[0-∞]) of Ramucirumab(Cycle 1 Day 1: Pre-Dose, End of Infusion: 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose)
- Progression-Free Survival (PFS)(Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks))
- Number of Participants With Anti-Ramucirumab Antibodies(Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion, Follow Up)
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)](Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks))
研究者
研究点 (1)
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