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

NCT05226169 | Recruiting Phase 3

• 1 other identifier: AMC2102
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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 effect of IV FCM on the treatment outcomes of palliative chemotherapy in patients with gastric cancer receiving fluoropyrimidine and platinum-based regimen in the same 1st-line palliative setting.

Conditions

Advanced Gastric Carcinoma

Outcome Measures

Primary Outcomes (1)

• Maximum change of Hb concentration

  Maximum change of Hb concentration from baseline to 12 weeks (or first RBC transfusion and/or ESA, or study withdrawl, or death, whichever will be first) without RBC transfusion and/or ESA

  baseline to 12 weeks

Secondary Outcomes (8)

• Change of Hb concentration

  baseline to 3, 6, 9, 12, 24, 36, and 48 weeks

• Change in serum iron

  baseline to 3, 6, 9, 12, 24, 36, and 48 weeks

• Change in serum ferritin

  baseline to 3, 6, 9, 12, 24, 36, and 48 weeks

• Change in serum TIBC

  baseline to 3, 6, 9, 12, 24, 36, and 48 weeks

• Change in serum TSAT

  baseline to 3, 6, 9, 12, 24, 36, and 48 weeks

Study Arms (2)

Active treatment arm : IV FCM

EXPERIMENTAL

Intravenous ferric carboxymaltose

Drug: Ferinject

Control treatment arm: Conservative management

ACTIVE COMPARATOR

Conservative management * Absolute IDA: oral ferrous sulfate * Functional IDA: no treatment or oral ferrous sulfate according to the physician's choice * Other IV iron or PRC transfusion or ESA therapy is not allowed

Other: Conservative management

Interventions

Ferinject DRUG

* Patients will receive an IV FCM (1,000 mg iron) infusion on the first day (visit 1) of chemotherapy. FCM (FerinjectTM; Vifor Pharma, Glattbrugg, Switzerland) will be diluted in 250 ml of sterile 0.9% normal saline by an aseptic technique and infused over 15 min under the supervision of a clinician. * Patients with a Hb level ≤ 10 g/dL and ID (serum ferritin \< 100 ng/mL or TSAT \< 50% and serum ferritin 100-500 ng/mL) will receive an additional dose of 500 mg of IV FCM at 6, 12, 24, 36, and 48 weeks. FCM will be diluted in 100 ml of sterile 0.9% normal saline by an aseptic technique and infused over 6 min under the supervision of a clinician.

Also known as: IV FCM

Active treatment arm : IV FCM

Conservative management OTHER

* Patients with absolute (must be administered) or functional (according to the physician's choice) IDA in the control arm will be received oral iron, administered as Feroba-You 256mg once or twice a day. Advice will be given regarding ingestion without food and with liquid high in ascorbic acid to maximize enteric absorption. * If patients in the control arm still meet the absolute or functional IDA at the end of study (at 48 weeks), they can receive IV FCM (1,000 mg) according to the physician's decision.

Control treatment arm: Conservative management

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Interventions

ferric carboxymaltose; Fosfomycin; Conservative Treatment

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Therapeutics

Central Study Contacts

Min-Hee Ryu, PhD

CONTACT

82-2-3010-5935; miniryu@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: February 7, 2022
• Study Start: April 29, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

KR (1)