TITRE |
Étude de phase 1b/3 associant Bermarituzumab/Chimiothérapie/Nivolumab versus Bermarituzumab/Chimiothérapie/Placebo chez les patients avec un adénocarcinome gastrique ou de la JGE non-traité, de stade avancé et surexprimant FGFR2b |
PROTOCOLE ID |
FORTITUDE-102 |
CLINICAL TRIAL.gov ID |
NCT05111626 |
TYPE(S) DE CANCER |
Estomac |
PHASE |
Phase I |
TYPE D'ÉTUDE |
Clinique |
INSTITUTION |
CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
|
VILLE |
Québec
|
INVESTIGATEUR(RICE) PRINCIPAL(E) |
Maxime Chénard-Poirier
|
COORDONATEUR(RICE) |
Maryse Gingras maryse.gringras@chudequebec.ca 418-691-5781
|
STATUT |
Fermé
|
CRITÈRES D'ÉLIGIBILITÉ |
(EN) Inclusion Criteria Part 1 and Part 2:
Additional Inclusion Criteria Part 2:
- No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment
- 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.
|
CRITÈRES D'EXCLUSION |
(EN)
- Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
- Known positive human epidermal growth factor receptor 2 (HER2) status
- Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
- Peripheral sensory neuropathy grade 2 or higher
- Clinically significant cardiac disease
- Other malignancy within the last 2 years (exceptions for definitively treated disease)
- Chronic or systemic ophthalmologic disorders
- Major surgery or other investigational study within 28 days prior to randomization
- Palliative radiotherapy within 14 days prior to randomization
- Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
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