EUCTR2021-003477-61-HU进行中（未招募）1 期
A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102)
Amgen Inc.0 个研究点目标入组 702 人开始时间: 2022年5月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 702
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
- •Inclusion Criteria Part 1:
- •- Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •- Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
- •- Participant must be a candidate to receive mFOLFOX6 and nivolumab
- •- Adequate organ function as follows:
- •Absolute neutrophil count = 1.5 x 10^9/L
- •Platelet count = 100 x 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 aminotransaminase (AST) and Alanine
- •aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x
- •ULN if liver involvement). Total bilirubin <1.5 x ULN (or < 2 x ULN if
- •liver involvement; or Gilbert's disease)
- •Calculated or measured creatinine clearance (CrCl) of = 50
- •mL/minute calculated using the formula of Cockcroft and Gault
- •International Normalized Ratio (INR) or prothrombin time (PT) <
- •1.5 × ULN except for participants receiving anticoagulation, who
- •must be on a stable dose of anticoagulant therapy for 6 weeks prior
- •to enrollment.
- •Subject has no contraindications to mFOLFOX6 chemotherapy or nivolumab
- •Additional Inclusion Criteria Part 2:
- •- No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment.
- •- Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive as determined by centrally performed immunohistochemistry (IHC) testing
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 162
排除标准
- •- Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
- •- Known positive human epidermal growth factor receptor 2 (HER2) status
- •- Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
- •- Peripheral sensory neuropathy grade 2 or higher
- •- Clinically significant cardiac disease
- •- Other malignancy within the last 2 years (exceptions for definitively treated disease)
- •- Chronic or systemic ophthalmologic disorders
- •- Major surgery or other investigational study within 28 days prior to randomization
- •- Palliative radiotherapy within 14 days prior to randomization
- •- Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
- •- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
- •Please refer to protocol for remaining exclusion criteria
研究者
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