| Titre |
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 |
| Protocole ID |
FORTITUDE-101 |
| ClinicalTrials.gov ID |
NCT05052801 |
| Type(s) de cancer |
Estomac
Oesophage |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Bemarituzumab + chimiothérapie versus placebo + chimiothérapie |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Petr Kavan
|
| Coordonnateur(trice) |
Aline Mamo
514-340-8222 poste 5525
|
| Statut |
 Actif en recrutement |
| Date d'activation |
05-01-2023 |
| Critètes d'éligibilité |
- Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
- Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive 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
|
| Critètes d'exclusion |
- 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
- Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
|
Groupe d'étude en oncologie du Québec