This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinue treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
5-Fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Unnamed facility
Denver, Colorado, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Fort Myers, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Niles, Illinois, United States
Unnamed facility
Albany, New York, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Nashville, Tennessee, United States
...and 26 more locations
Progression-free survival (PFS) in all patients
Time frame: Up to 18 months
Progression-free survival (PFS) in patients with Met-positive tumors
Time frame: Up to 18 months
Safety: incidence of adverse events
Time frame: 18 months
Overall survival (OS)
Time frame: 18 months
Overall response rate (ORR)
Time frame: 18 months
Duration of response (DOR)
Time frame: 18 months
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