Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®

Study Overview
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Brief Summary
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Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.

Detailed Description
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This is a Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized into the trial (Group A or B).

Official Title
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IRON CLAD: Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Multi-center, Randomized, Double-blinded, Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose Injection) in Adults

Conditions
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Cancer and Chemotherapy Related Anemia

Intervention / Treatment
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* Drug: Injectafer
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects (male of female) ≥ 18 years of age able to give informed consent to the study. Subjects with non-myeloid malignancies Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of treatment remaining. Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL. Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =<35% Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of 0-2. Life expectancy of at least 6 months. Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments. Exclusion Criteria: Previous participation in a ferric carboxymaltose clinical trial. Known hypersensitivity reaction to any component of ferric carboxymaltose. Subjects with overt bleeding Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion, or erythropoiesis-stimulating agents). Subjects on erythropoiesis-stimulating agents. Requiring dialysis for the treatment of chronic kidney disease. Any non-viral infection. Known positive hepatitis with evidence of active disease. Received an investigational drug within 30 days of screening. Alcohol or drug abuse within the past 6 months. Hemochromatosis or other iron storage disorders. Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements. Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injectafer<br>2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. | Drug: Injectafer<br> <br> * Other names: ferric carboxymaltose injection;|
| Placebo Comparator: Normal Saline<br>Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. | Other: Normal Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18 | The following participants will be considered to have met the primary endpoint: Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18. Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit. Participants who have a non-study intervention prior to Week 18. Participants who discontinue prior to Week 18 for lack of efficacy or adverse events. | Week 3 to Week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention | Nonstudy Intervention is defined as any of the following: Initiation of erythropoietin for any reason Blood transfusion IV iron Prescribed use of oral iron | Baseline to Week 18 | 
| Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention | Summary of number and percentage(%) of participants with Hgb increase ≥ 1 g/dL increase at any time point in the absence of non-study intervention. | Baseline to Week 18 | 
| Percentage of Participants Who Received Nonstudy Intervention | Intervention is defined as any of the following: Initiation of erythropoietin for any reason Blood transfusion IV iron Prescribed use of oral iron | Baseline to week 18 | 
| Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention | Intervention is defined as any of the following: Initiation of erythropoietin for any reason Blood transfusion IV iron Prescribed use of oral iron | Baseline to week 18 | 
| Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention | Participants who discontinued or completed the study, or received a non-study intervention before having an increased in Hgb ≥ 1 g/dL will be censored at last study visit or time of receiving non-study intervention, respectively | Baseline to Week 18 | 
| Percentage of Participants Requiring a Blood Transfusion | Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial. | Baseline to week 18 | 
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Baseline to Day 7 | 
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Baseline to Week 2 | 
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Baseline to Week 3 | 
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Baseline to Week 6 | 
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Baseline to Week 9 | 
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Baseline to Week 12 | 
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Baseline to Week 15 | 
| Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit | Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit. | Baseline to Week 18 | 
| Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively. | Baseline to Week 18 | 
| Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 | Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively. | From Baseline to Week 18 | 
| Correlation of Change in Hemoglobin With Baseline Hepcidin Level | For participants who receive non-study intervention or early withdraw from the study, the time of intervention or early withdrawal will be considered as end of study, respectively. | Baseline to Week 18. | 
| Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 | Summary of the actual value and change from baseline in total score of Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue Scale). Ranges from 0-52 and higher scores mean better Quality of Life (QOL). Data collected after receiving non-study intervention will not be included in the summary. | Baseline to Week 18 |