NCT04923932已完成2 期
A Multi-center, Open-label, Phase II Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Savolitinib in Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients With MET Gene Amplifications
Hutchison Medipharma Limited1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年7月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
研究概览
简要总结
Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib
详细描述
This is a single-arm, multi-cohort, multi-center, open-label, phase II clinical study. The objective is to evaluate the efficacy and safety of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications. The study involves a Screening Period, a Treatment Period and a Follow-up Period. It had 54 study sites and enrolled/dosed 110 patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
- •Age ≥18 years;
- •Histologically diagnosed locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma
- •MET gene amplifications
- •Cohort 1 & 3: Having measurable lesions (in accordance with RECIST 1.1 criteria); Cohort 2: having evaluable lesions
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- •Survival is expected to exceed 12 weeks;
- •Adequate functionality in bone marrow, liver, kidney
- •Able to take or swallow the drug orally.
- •Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 4 weeks after discontinuation of the study drug, The male patients whose sexual partners are women of childbearing age must use condom during sexual intercourse during the study and within 6 months after discontinuation of study drug;
排除标准
- •Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have small possibility of recurrence. Patients with radically treated carcinoma in situ (non-infiltrating) and skin cancer other than malignant melanoma can be enrolled;
- •Having received antitumor therapy (including chemotherapy, hormone therapy, biotherapy, immunotherapy or traditional Chinese medicine for antitumor indication) within 3 weeks prior to the start of study treatment, or having received treatment with small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeks prior to the start of study treatment;
- •Received extensive radiotherapy within 4 weeks of treatment
- •Received close distance radiotherapy within 60 days
- •Major surgery within 4 weeks of treatment
- •Taken strong CYP3A4 inducer within 2 weeks
- •Not recovered from past anti-tumor treatment toxicity
- •Active HIV infection
- •Active Hepatitis B or C infection
研究组 & 干预措施
Savolitinib
Experimental
GC
干预措施: Savolitinib (Drug)
结局指标
主要结局
Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months
To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
次要结局
- Progression-free survival (PFS) (RECIST 1.1 criteria)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months)
- incidence of various adverse events (AE)(through study completion, an average of 3.5 year)
研究者
研究点 (1)
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