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20210096 - FORTITUDE-101 - 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

Studio Clinico

Patologia: Neoplasie dello stomaco, Tumori dell’esofago

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

Bemarituzumab with mFOLFOX6

Trattamento di controllo: 

Placebo with mFOLFOX6

Obiettivi primari dello studio: 

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).

Centri partecipanti

Nord Italia

Fondazione Poliambulanza Istituto Ospedaliero
Via Bissolati 57 - 25124 Brescia - BS

Riferimento: Prof. Alberto Zaniboni
Telefono: 0303515553


Grande Ospedale Metropolitano Niguarda
Piazza Ospedale Maggiore 3 - 20162 Milano - MI

Riferimento: Prof. Salvatore Siena
Telefono: 0264442291


Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Telefono: 0282244080


AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE

Riferimento: Dr.ssa Angela Damato
Telefono: 0522296858


AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO

Riferimento: Prof. Massimo Di Maio
Telefono: 0115082032


Azienda Ospedaliera Santa Maria della Misericordia
Piazzale Santa Maria della Misericordia 15 - 33100 Udine - UD


AOUI Verona - Borgo Trento
Piazzale Aristide Stefani 1 - 37126 Verona - VR

Riferimento: Dr. Michele Pavarana


Centro Italia

Azienda Ospedaliera S. Giovanni Addolorata Roma
Via Dell’Amba Aradam 9 - 00184 Roma - RM

Riferimento: Dr. Mauro Minelli
Telefono: 0677052874


Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM


Sud Italia e isole

AOU di Cagliari - Presidio Policlinico Monserrato
St.Statale 554, Km 4500 - 09100 Monserrato - CA

Riferimento: Prof. Mario Scartozzi
Telefono: 07051096107


Presidio Ospedaliero Garibaldi Nesima
Via Palermo 636 - 95122 Catania - CT


Presidio Ospedaliero Vito Fazzi Asl Lecce
Piazzetta F. Muratore - 73100 Lecce - LE


Ospedale 'Card. G. Panico'
Via San Pio X 4 - 73039 Tricase - LE

Riferimento: Dr. Emiliano Tamburini
Telefono: 0833773111

Informazioni Generali


Numero di iscrizione a registro: 2021-003461-35

Data di inserimento: 23.02.2023



Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000


Localita: -


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