JPRN-jRCT2031220049招募中3 期
A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
Kaneda Hirokazu0 个研究点目标入组 516 人开始时间: 2022年4月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 516
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 100age old（—）
- 性别
- All
入选标准
- •1. Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
- •2. Fibroblast growth factor receptor 2b (FGFR2b) >= 10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
- •3. Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
- •4. Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
- •5. Participant has no contraindications to mFOLFOX6 chemotherapy
- •6. Adequate organ and bone marrow function:
- •- absolute neutrophil count greater than or equal to 1.5 times 10^9/L
- •- platelet count greater than or equal to 100 times 10^9/L
- •- hemoglobin >= 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
- •- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
- •- calculated or measured creatinine clearance (CrCl) of >= 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) x Mass [kg]/[72 x Creatinine mg/dL]) (x 0.85 if female)- international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
排除标准
- •1. Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
- •2. Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
- •3. Known human epidermal growth factor receptor 2 (HER2) positive
- •4. Untreated or symptomatic central nervous system (CNS) disease or brain metastases
- •5. Peripheral sensory neuropathy greater than or equal to Grade 2
- •6. Clinically significant cardiac disease
- •7. Other malignancy within the last 2 years (exceptions for definitively treated disease)
- •8. Chronic or systemic ophthalmological disorders
- •9. Major surgery or other investigational study within 28 days prior to first dose of study treatment
- •10. Palliative radiotherapy within 14 days prior to the first dose of study treatment
- •11. Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
研究者
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