A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)
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Five Prime Therapeutics, Inc.
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 14, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | September 14, 2018 | ||
| 预计主要完成日期 | July 1, 2022 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Overall Survival (OS)[ Time Frame: up to approximately 46 months ] Time from enrollment until death from any cause |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT) | ||
| 正式标题 ICMJE | FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 3 Preceded by Dose-Finding in Phase 1 | ||
| 简要概况 | This is a global, randomized, double-blind, controlled study to evaluate the efficacy of bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification) |
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| 详细说明 | The main purpose of this study is to evaluate the efficacy of bemarituzumab (FPA144), which is a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with Gastric Cancer as measured by overall survival. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 3 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述:Double blinded (participant, treating physician) 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
548 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | July 1, 2024 | ||
| 预计主要完成日期 | July 1, 2022 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Key Inclusion Criteria: - Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - Adequate hematological, liver and kidney function. Measurable or non-measurable, but evaluable disease using RECIST v1.1 - FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay - Candidate for mFOLFOX6 chemotherapy Key Exclusion Criteria: - Untreated or symptomatic central nervous system (CNS) metastases - Clinically significant cardiac disease, - Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 - Active infection requiring systemic treatment - Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection - Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway - Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer - Known positivity for HER2 - Women who are pregnant or breastfeeding Note: Other protocol defined Inclusion/Exclusion criteria may apply | ||
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Five Prime Therapeutics, Inc. | ||
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| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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