About this trial
This is a randomized, international multi-center, double blind, placebo-controlled Phase III study where patients with gastric cancers with Fibroblast Growth Factor Receptor 2b (FGFR2b) overexpression will be randomized to either bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) or Placebo plus mFOLFOX6.
Patient Profile
Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer which shows FGFR2b over expression and is not amenable to curative therapy
Where’s this trial being run?
St James’s Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | FORTITUDE-101 |
|---|---|
| Number: | 23-17 |
| Full Title: | 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 |
| Principal Investigator: | Prof Maeve Lowery (St. James' Hospital) |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | Amgen Inc. |
| Recruitment Started: |
Global: March 2022 Ireland: December 2023 |
| Global Recruitment Target: | 516 |
|---|---|
| Ireland Recruitment Target: | 6 |