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 1 人开始时间: 2023年12月11日最近更新: 2024年8月20日

适应症

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方: Amgen, Inc.
入组人数: 1

研究概览入排标准研究者记录与标识符相似试验

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

•101 Subject has provided informed consent prior to initiation of any study specific activities/procedures.
•102 Age = 18 years (or legal adult age within country, whichever is older)
•103 Histologically documented gastric or GEJ adenocarcinoma (not amenable to curative therapy).
•Primary tumor location will be classified following the American Joint Committee on Cancer/Union for International Cancer Control [AJCC/UICC] 8th edition.
•104 Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
•105 FGFR2b = 10% 2+/3+ TC as determined by centrally performed 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.
•106 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
•107 Adequate organ function as follows:
•absolute neutrophil count = 1.5 x 109/L
•platelet count = 100 x 109/L
•hemoglobin = 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
•aspartate aminotransferase and ALT < 3x 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; with the exception of subjects with Gilbert’s disease)
•calculated or measured creatinine clearance (CrCl) of = 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 – Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
•international normalized ratio or prothrombin time (PT) < 1.5 × ULN except for subjects receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
•108 Measurable disease or non-measurable, but evaluable disease, according to RECIST v1.1.
•109 Subject has no contraindications to mFOLFOX6 chemotherapy

排除标准

•Disease Related
•201 Untreated or symptomatic central nervous system (CNS) metastases and leptomeningeal disease
•Subjects with asymptomatic CNS metastases are eligible if clinically stable for at least 4 weeks and do not require intervention (including use of corticosteroids).
•Subjects with treated brain metastases are eligible provided the following criteria are met:
•- Definitive therapy was completed at least 2 weeks prior to the first planned dose of study treatment (stereotactic radiosurgery at least 7 days prior to first planned dose of study treatment)
•- At least 7 days prior to first dose of study treatment: any CNS disease is clinically stable, subject is off steroids for CNS disease (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs
•Other Medical Conditions
•202 Impaired cardiac function or clinically significant cardiac disease including: unstable angina within 6 months prior to first dose of study treatment, acute myocardial infarction < 6 months prior to first dose of study treatment, New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension (defined as an average systolic blood pressure > 160 mmHg or diastolic > 100 mm Hg despite optimal treatment (measured following European Society for Hypertension/European Society of Cardiology [ESH/ESC] 2018 guidelines); uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease, QTc = 470 msec
•203 Peripheral sensory neuropathy G2 or higher
•204 Active infection requiring systemic treatment or any uncontrolled infection equal or less than 14 days prior to first dose of study treatment
•205 Known positive HER2 status (as defined by positive IHC test of 3+ or IHC 2+ with positive in situ hybridization [ISH])
•206 Known human immunodeficiency virus (HIV) infection with CD4+ T-cell (CD4+) counts < 350 cells/µL, hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response following antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen [SAg] or core antibody that achieve sustained virologic response with antiviral therapy directed at hepatitis B are allowed)
•207 History of interstitial lung disease
•208 History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids
•209 Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing
•210 Unwillingness to avoid use of contact lenses during study treatment
•211 Major surgical procedure within 28 days prior to first dose of study treatment
•212 History of other malignancy within the past 2 years, except:
•curatively treated non-melanoma skin malignancy
•cervical cancer in situ
•curatively treated uterine cancer stage I
•curatively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapy
•localized prostate cancer that has been treated surgically with curative intent and presumed cured
•213 Evidence of, or recent (within 6 months) history 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 developin

研究者

发起方

Amgen, Inc.

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