A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction adenocarcinoma (GEJ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or
- •Tumor MET-positive by immunohistochemistry (IHC).
- •Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- •Male or female subject greater than or equal to 20 years of age at the time of informed consent.
排除标准
- •Human epidermal growth factor receptor 2 (HER2)-overexpressing locally advanced or metastatic gastric or GEJ adenocarcinoma.
- •Previous systemic therapy for locally advanced or metastatic gastric or GEJ or lower esophageal adenocarcinoma.
- •Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization.
- •Squamous cell histology.
研究组 & 干预措施
Rilotumumab
Rilotumumab plus Cisplatin and Capecitabine (CX).
干预措施: Rilotumumab (Drug)
Rilotumumab
Rilotumumab plus Cisplatin and Capecitabine (CX).
干预措施: Cisplatin (Drug)
Rilotumumab
Rilotumumab plus Cisplatin and Capecitabine (CX).
干预措施: Capecitabine (Drug)
Placebo
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
干预措施: Placebo (Drug)
Placebo
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
干预措施: Cisplatin (Drug)
Placebo
Rilotumumab-placebo plus Cisplatin and Capecitabine (CX).
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 4 years
To determine if the treatment of rilotumumab in combination with CX significantly improves progression-free survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression.
Overall Survival
时间窗: 4 years
To determine if the treatment of rilotumumab in combination with CX significantly improves overall survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression.
次要结局
- TTP(4 years)
- ORR(4 years)
- DCR(4 years)
- TTR(4 years)
- Incidence of subject adverse events, laboratory abnormalities and immunogenicity(4 years)