NCT01874938已完成2 期
A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Progression Free Survival (PFS) Rate
研究概览
简要总结
The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer.
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
- •Have a diagnosis of a histopathologically or cytologically confirmed local and/or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma which is unresectable
- •Have received 2 regimens of prior chemotherapies for gastric or GEJ adenocarcinoma
- •Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- •Have consent to provide a tissue sample for pre-screening
- •Determined to be MET diagnostic positive based upon testing of a tumor sample obtained at any time before enrollment
- •Have discontinued all previous treatments for cancer, including chemotherapy and radiotherapy, for at least 3 weeks before enrollment and have recovered from the acute effects of therapy
- •Have adequate organ function
- •Male participants: must agree to use a reliable method of birth control and to not donate sperm during the study and for at least 4 months following last dose of study drug or country requirements, whichever is longer
- •Female participants: are women of child-bearing potential who test negative for pregnancy ≤14 days before enrollment based on a serum pregnancy test and agree to use a reliable method of birth control during the study and for 4 months following the last dose of the study drug and must also not be breastfeeding
- •Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
- •Have an estimated life expectancy, in the judgment of the investigator, of at least 12 weeks
排除标准
- •Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have previously completed or withdrawn from this study or any other study investigating LY2875358
- •Have an active fungal, bacterial, and/or known viral infection
- •Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction (MI) in 6 months prior to study drug administration
- •Have symptomatic central nervous system (CNS) malignancy or metastasis
- •Have previous or concurrent malignancies
- •Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C
- •Have corrected QT interval (QTc) of >470 millisecond (msec) on screening electrocardiogram (ECG)
- •Have received previous treatment with any hepatocyte growth factor (HGF)/MET targeting therapeutics
- •Have a history of radiation therapy involving more than 25% of the bone marrow. Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation
结局指标
主要结局
Progression Free Survival (PFS) Rate
时间窗: 8 Weeks
次要结局
- PFS(Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months))
- Proportion of Participants who Exhibit Stable Disease (SD) or Confirmed CR or PR (Disease Control Rate [DCR])(Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months))
- Overall Survival (OS)(Baseline to Death from Any Cause (Estimated up to 6 Months))
- Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])(Baseline to Confirmed CR or PR (Estimated up to 4 Months))
- Duration of Response(Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months))
- Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358(Baseline to Study Completion (Estimated up to 4 Months))
- Pharmacokinetics (PK): Volume of distribution (V) of LY287358(Baseline to Study Completion (Estimated up to 4 Months))
研究者
研究点 (4)
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