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Active (not recruiting) Phase 3 NCT05052801

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

Phase 3 – large-scale trial before approval
Conditions: Gastric Cancer Gastroesophageal Junction Adenocarcinoma

Sponsor: Amgen

trial.available_in: БГ
Overview
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)
Who can participate
Inclusion Criteria: * 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.
Locations 36
Argentina (1)
Instituto Alexander Fleming
CABA , Buenos Aires
Australia (1)
Liverpool Hospital
Liverpool , New South Wales
Belgium (1)
Universitair Ziekenhuis Antwerpen
Edegem
Brazil (1)
Núcleo de Oncologia da Bahia
Salvador , Estado de Bahia
Bulgaria (1)
Multiprofile Hospital for Active Treatment Park Hospital EOOD
Branipole Village
Canada (1)
Cross Cancer Institute
Edmonton , Alberta
Chile (1)
James Lind Centro de Investigacion del Cancer
Temuco , Cautín
China (1)
The First Affiliated Hospital of Bengbu Medical College
Bengbu , Anhui
Colombia (1)
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
Rionegro , Antioquia
Czech Republic (1)
Masarykuv onkologicky ustav
Brno
Denmark (1)
Rigshospitalet
Copenhagen
Estonia (1)
North Estonia Medical Centre Foundation
Tallinn
France (1)
Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
Amiens
Greece (1)
Agios Savvas Anticancer Hospital
Athens
Hungary (1)
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr
Ireland (1)
St James Hospital
Dublin
Israel (1)
Assuta Medical Center
Jerusalem
Italy (1)
Istituto Ospedaliero Fondazione Poliambulanza
Brescia
Japan (1)
Aichi Cancer Center
Nagoya , Aichi-ken
Latvia (1)
Pauls Stradins Clinical University Hospital
Riga
Lithuania (1)
Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos
Kaunas
Malaysia (1)
Hospital Kuala Lumpur
Kuala Lumpur , Kuala Lumpur
Mexico (1)
Centro Oncologico Internacional
Tijuana , Baja California Norte
Norway (1)
Oslo University Hospital
Oslo
Peru (1)
Centro de Investigacion Clinica Trujillo Eirl
Trujillo , La Libertad
Poland (1)
Centrum Onkologii im prof Franciszka Lukaszczyka
Bydgoszcz
Romania (1)
Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare
Baia Mare
Singapore (1)
National Cancer Centre Singapore
Singapore
South Africa (1)
The Oncology Centre
Durban
South Korea (1)
Dong-A University Hospital
Busan
Spain (1)
Hospital Universitario Reina Sofia
Córdoba , Andalusia
Sweden (1)
Sahlgrenska Universitetssjukhuset
Gothenburg
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Thailand (1)
King Chulalongkorn Memorial Hospital
Bangkok
Turkey (1)
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
Adana
United States (1)
Alaska Oncology and Hematology
Anchorage , Alaska
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
07.03.2022
Completion date
20.06.2026
Registry ID
NCT05052801
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.