Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Amgen (Voir sur ClinicalTrials)
mars 2022
juin 2026
02 octobre 2025
The main objective of this study is to compare efficacy of bemarituzumab combined with
oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as
assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell
staining (FGFR2b ≥10% 2+/3+TC)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Val�rie BOIGE | 27/03/2024 08:14:05 | Contacter | ||
Critères
Tous
- Adults with histologically documented unresectable, locally advanced or metastatic
gastric or gastroesophageal junction cancer not amenable to curative therapy
- Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as
determined 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
- Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
- Measurable disease or non-measurable, but evaluable disease, according to Response
Evaluation Criteria in Solid Tumors (RECIST) V 1.1
- Participant has no contraindications to mFOLFOX6 chemotherapy
- 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 ≥ 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 ≥ 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 (INR) or prothrombin time (PT) less than 1.5
times ULN except for participants receiving anticoagulation, who must be on a
stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Exclusion Criteria:
- Prior treatment for metastatic or unresectable disease (Note: prior adjuvant,
neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months
prior to first dose of study treatment)
- Prior treatment with any selective inhibitor of fibroblast growth factor -
fibroblast growth factor receptor (FGF-FGFR) pathway
- Known human epidermal growth factor receptor 2 (HER2) positive
- Untreated or symptomatic central nervous system (CNS) disease or brain metastases
- Peripheral sensory neuropathy greater than or equal to Grade 2
- Clinically significant cardiac disease
- Other malignancy within the last 2 years (exceptions for definitively treated
disease)
- Chronic or systemic ophthalmological disorders
- Major surgery or other investigational study within 28 days prior to first dose of
study treatment
- Palliative radiotherapy within 14 days prior to the first dose of study treatment
- Evidence of or recent history (within 6 months) 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 developing a
corneal ulcer.