Status:
RECRUITING
Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)
Lead Sponsor:
Asan Medical Center
Conditions:
Advanced Gastric Carcinoma
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The main objective of this study is to evaluate the efficacy and safety of IV FCM(ferric carboxymaltose) in patients with AGC receiving palliative chemotherapy. This study will also evaluate the effec...
Detailed Description
Gastric cancer is associated with chronic blood loss, poor nutrition, and surgical interventions interfering with iron absorption, all of which synergistically increase the risk of iron-deficiency ane...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT05226169
Start Date
April 29 2022
End Date
November 30 2024
Last Update
February 28 2024
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736