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Iron

Ferric Compounds

Ferinject to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50 Kg .

Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® must be diluted only in sterile 0.9% sodium chloride.

Strength/Packaging: 10 mL vials containing 500 mg iron as iron per vial.

Ferinject® to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50 Kg .

Study drug may be administered as IV drip infusion or IV undiluted bolus injection.

Ferinject (Ferric Carboxymaltose)

Sang Jae Park, M.D

This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.

Primary objectives : Perioperative transfusion rate (including preop, intraop, postop≦7 days).

Secondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.

Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy

To evaluate reducing transfusion rate during perioperative period

To investigate the association between the number of participants with complications and hospital length of stay(days)

change of hematology parameters value of Hb in g/dL,

* ferritin in ng/ml
* transferrin saturation in % (TSAT) after Ferinject® administration)

assessment of adverse effect with Ferinject® administration

JW Pharmaceutical

National Cancer Center, Korea

Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch

Stomach Neoplasms

Hematologic Diseases

Stomach Cancer

Acute Graft Versus Host Disease

Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with 7g/dl≤Hb\<10g/dl at 5 - 7 days after gastrectomy for gastric cancer.

Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with 7g/dl≤Hb\<10g/dl at 5 - 7 days after gastrectomy for gastric cancer.

Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50Kg .

Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight \<50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value \<15ng/mL and Hb\<10g/dl at week 3 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)

Ferinject®

Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight \<50 Kg.

normal saline

Young Woo Kim, PhD

This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective measures (Hb and iron parameters).

Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.

Randomized patient-blind placebo controlled study. Hb level of 10 g/dl will be used as a cut-off value for our study based on the guidelines published by American Society of Clinical Oncology and the American Society of Hematology for the treatment of cancer-related anemia, recommending Hb\<10 g/dl as a treatment threshold.

Ferinject® to be administered based on Hb and body weight per approved summary of product characteristics (SmPC).

5 - 7 days after gastrectomy for gastric cancer, consented patients with 7g/dl≤Hb\<10g/dl will be administered Ferinject® or placebo (normal saline) based on the results of randomization.

• Study Group Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50Kg .

Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight \<50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value \<15ng/mL at week 4 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)

• Control Group Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight \<50 Kg.

Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)

A Randomized Patient -Blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject®) With Placebo in Patients With Acute Isovolemic Anemia After Gastrectomy

• Number of responders (Hb increase ≥2 g/dL with respect to the baseline Hb value and/or Hb ≥11g/dL ) by 12 weeks (independent of alternative anaemia management including transfusion or ESA use). Note, if patient requires an ESA or blood transfusion by week 12 will be considered a non-responder.

• Percentage of patients with Hb ≥10, 11 and 12 g/dL at 3 and 12 weeks (independent of alternative anaemia management including transfusion or ESA use)

• Percentage of patients requiring alternative anaemia management therapy

• Self-reported patient assessment of EORTC QLQ C-30 and Sto-22 at 3 weeks and 12 weeks

• Evolution of Hb, ferritin and TSAT over the study duration (12weeks) independent of alternative anaemia management including transfusion or ESA use

• adverse events: type, nature, incidence and outcome

Head of Department of Gastric Cancer Research

JiYoung Choi

* Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
* Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
* Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
* In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy	NCT02628860	Pancreatic Canc... Anemia	Ferinject (Ferr...	19 Years -	National Cancer Center, Korea
Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)	NCT01725789	Anemia	Ferinject® normal saline	20 Years -	National Cancer Center, Korea
Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)	NCT01725789	Anemia	Ferinject® normal saline	20 Years -	National Cancer Center, Korea
The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients	NCT02599012	Cancer Anemia	Ferinject®	18 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for ferinject®

Every month we try and update this database with for ferinject® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ferinject®

Every month we try and update this database with for ferinject® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ferinject® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.