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

Prior treatment

• History of ESA, IV or oral iron therapy, and/or RBC transfusion 4 weeks prior to randomization

Other illness

• Ongoing bleeding or overt gross active bleeding (e.g., hematemesis, melena, or hematochezia)
• 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)
• 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)

Lab values

• 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)
• 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

Other

• Body weight \< 35 kg
• Neoplastic bone marrow infiltration
• 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.

• Age ≥ 19 years at the time of study registration
• Eastern Cooperative Oncology Group performance status ≤ 2
• Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma
• Locally advanced unresectable or metastatic disease
• Patients who have not been treated with palliative systemic antitumor agents for advanced or recurrent gastric or GEJ adenocarcinoma
• Patients scheduled to receive palliative first-line fluoropyrimidine and platinum-based systemic therapy including targeted therapy or immunotherapy
• Life expectancy ≥24 weeks
• IDA
  • Hb 8 to \<11 g/dL
  • Absolute ID (serum ferritin \< 100 ng/mL) OR functional ID (TSAT\* \< 50% and serum ferritin 100-500 ng/mL)
  • TSAT = (serum iron level x 100)/ total iron-binding capacity (TIBC)