Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)

Exclusion Criteria15

• Body weight < 35 kg
• Immediate need for transfusion or Hb < 8 g/dL
• Possible functional ID or No ID (serum ferritin > 500 ng/mL OR TSAT ≥ 50%)
• Anemia attributable to factors other than cancer or chemotherapy (e.g., vitamin B12 and/or serum folate deficiency; hemolysis; or myelodysplastic syndromes)
• Ongoing bleeding or overt gross active bleeding (e.g., hematemesis, melena, or hematochezia)
• Neoplastic bone marrow infiltration
• History of ESA, IV or oral iron therapy, and/or RBC transfusion 4 weeks prior to randomization
• Iron overload or disturbances in utilization of iron (e.g., personal or family history of hemochromatosis and hemosiderosis)
• Known hypersensitivity to any of the required study products or known serious hypersensitivity to other parenteral iron products
• Known severe allergies including drug allergies, history of severe asthma, eczema or other atopic allergies, and in subjects with immune or inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis)
• Decreased renal function including renal dialysis (previous, current or planned within the next 6 months,) or serum creatinine levels ≥ 2.0 mg/dL, or estimated glomerular filtration rate < 30 mL/min/1.73 m2
• Chronic liver disease (including active hepatitis) and/or aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 3 times the upper limit of the normal range
• Active acute or chronic infections (assessed by clinical judgment)
• Other significant medical condition(s) in the opinion of the investigator with an anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the subject or may interfere with study assessments, outcomes (e.g., uncontrolled hypertension, active cardiac disease, thromboembolic disease, or uncontrolled diabetes mellitus, neurological or psychiatric disorders)
• Pregnancy (e.g., positive human chorionic gonadotropin test) or breast-feeding. If the subject is of childbearing potential and does, not use adequate contraceptive precautions. The subject must agree to use adequate contraception during the study and for 1 month after the last dose of study treatment. A highly effective method of birth control must be used.