EUCTR2021-003461-35-HUActive, not recruitingPhase 1
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 sites516 target enrollmentStarted: November 17, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 516
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
- •2.Confirmed fibroblast growth factor receptor 2b (FGFR2b) overexpression by immunohistochemistry (IHC) (central testing result)
- •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
- •- 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 Gault
- •- 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
Exclusion Criteria
- •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
Investigators
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