EUCTR2021-003461-35-CZ进行中（未招募）1 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 (FORTITUDE-101)
Amgen Inc.0 个研究点目标入组 516 人开始时间: 2021年11月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- All
入选标准
- •1.Adults with unresectable, locally advanced or metastatic gastric or
- •gastroesophageal junction cancer not amenable to curative therapy
- •2.Confirmed FGFR2b =10% 2+/3+ TC by centrally performed
- •immunohistochemistry (IHC) testing, based on tumor sample either
- •archival (obtained within 6 months/180 days prior to signing prescreening
- •informed consent) or a fresh biopsy
- •3.Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
- •4.Measurable, evaluable, or non-evaluable disease as long as evaluable
- •by Response Evaluation Criteria in Solid Tumors (RECIST) version 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 greater than or equal to 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 greater than or
- •equal to 30 mL/minute calculated using the formula of Cockcroft and
- •- 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 warfarin for 6 weeks prior to enrollment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 116
排除标准
- •1.Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose)
- •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 of randomization
- •10.Palliative radiotherapy within 14 days of randomization
- •11.Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
研究者
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