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

Phase 3

Completed

Conditions: Cancer and Chemotherapy Related Anemia

Interventions: Other: Normal Saline
Drug: Injectafer

Registration Number: NCT02453334

Lead Sponsor: American Regent, Inc.

Brief Summary: 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: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 244

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Injectafer	Injectafer	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention	Baseline to Week 18	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.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit	Baseline to Week 18	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Percentage of Participants Who Received Nonstudy Intervention	Baseline to week 18	Intervention is defined as any of the following: * Initiation of erythropoietin for any reason * Blood transfusion * IV iron * Prescribed use of oral iron
Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention	Baseline to week 18	Intervention is defined as any of the following: * Initiation of erythropoietin for any reason * Blood transfusion * IV iron * Prescribed use of oral iron
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention	Baseline to Week 18	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
Percentage of Participants Requiring a Blood Transfusion	Baseline to week 18	Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention	Baseline to Week 18	Nonstudy Intervention is defined as any of the following: * Initiation of erythropoietin for any reason * Blood transfusion * IV iron * Prescribed use of oral iron
Correlation of Change in Hemoglobin With Baseline Hepcidin Level	Baseline to Week 18.	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.
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.	Baseline to Week 15	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18	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.
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18	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.

Trial Locations

Locations (27): Lakes Research
🇺🇸
Miami Lakes, Florida, United States
Michiana Hematology Oncology, PC
🇺🇸
South Bend, Indiana, United States
Compassionate Care Research Group, Inc.
🇺🇸
Riverside, California, United States
Kinston Medical Specialists
🇺🇸
Kinston, North Carolina, United States
Westchase Clinical Associates
🇺🇸
Houston, Texas, United States
Charleston Hematology/Oncology Associates, P.A.
🇺🇸
Charleston, South Carolina, United States
University Cancer Institute
🇺🇸
Boynton Beach, Florida, United States
Bond Bond Clinic, P.A.
🇺🇸
Winter Haven, Florida, United States
Joliet Oncology Hematology Associates
🇺🇸
Joliet, Illinois, United States
Antietam Oncology and Hematology Group, P.C.
🇺🇸
Hagerstown, Maryland, United States
Waverly Hematology Oncology
🇺🇸
Cary, North Carolina, United States
H. Lee Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
AR Development Solutions
🇺🇸
Miami Lakes, Florida, United States
North Mississippi and Oncology Associates
🇺🇸
Tupelo, Mississippi, United States
Richmond University Medical Center
🇺🇸
Staten Island, New York, United States
Rcca Md, Llc
🇺🇸
Bethesda, Maryland, United States
OSF Saint Anthony Medical Center for Cancer Care
🇺🇸
Rockford, Illinois, United States
MId-Illinois Hematology & Oncology Associates, Ltd.
🇺🇸
Normal, Illinois, United States
Northern Indiana Cancer Research Consortium
🇺🇸
South Bend, Indiana, United States
The Brookdale University Hospital and Medical Center
🇺🇸
Brooklyn, New York, United States
Gettysburg Cancer Center
🇺🇸
Gettysburg, Pennsylvania, United States
Carolina Blood and Cancer Care, PA
🇺🇸
Rock Hill, South Carolina, United States
Horizon Oncology Research, Inc.
🇺🇸
Lafayette, Indiana, United States
Ashland-Bellefonte Cancer Center
🇺🇸
Ashland, Kentucky, United States
Bon Secours St. Francis Medical Center
🇺🇸
Midlothian, Virginia, United States
East Chester Cancer Center
🇺🇸
Bronx, New York, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States