JPRN-jRCT2080224734已完成2 期
FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1
Five Prime Therapeutics, Inc. (ICCC: ICON JAPAN K.K.)0 个研究点目标入组 155 人开始时间: 2019年6月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
研究概览
简要总结
Overall, the results of final analysis phase 2 study suggest that 15 mg/kg bemarituzumab administered Q2W as a 30-minute infusion and a single dose of 7.5 mg/kg on day 8 of cycle 1 in combination with mFOLFOX6 demonstrated an acceptable safety profile and evidence of clinical response for FGFR2b positive selected subjects with previously untreated gastric and GEJ adenocarcinoma.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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