Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpressio

Phase 1

• Conditions: ntreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression; MedDRA version: 23.1Level: LLTClassification code 10084227Term: Gastroesophageal junction cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003461-35-NO
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-08
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

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 pre-screening 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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified