Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
NCT ID: NCT02453334
Last Updated: 2021-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
244 participants
INTERVENTIONAL
2015-05-23
2018-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Injectafer
Normal Saline
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
Interventions
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Injectafer
Normal Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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American Regent, Inc.
INDUSTRY
Responsible Party
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Locations
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Compassionate Care Research Group, Inc.
Corona, California, United States
Compassionate Care Research Group, Inc.
Fountain Valley, California, United States
Compassionate Care Research Group, Inc.
Riverside, California, United States
University Cancer Institute
Boynton Beach, Florida, United States
AR Development Solutions
Miami Lakes, Florida, United States
Lakes Research
Miami Lakes, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Bond Bond Clinic, P.A.
Winter Haven, Florida, United States
Joliet Oncology Hematology Associates
Joliet, Illinois, United States
MId-Illinois Hematology & Oncology Associates, Ltd.
Normal, Illinois, United States
OSF Saint Anthony Medical Center for Cancer Care
Rockford, Illinois, United States
Horizon Oncology Research, Inc.
Lafayette, Indiana, United States
Michiana Hematology Oncology, PC
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, United States
Rcca Md, Llc
Bethesda, Maryland, United States
Antietam Oncology and Hematology Group, P.C.
Hagerstown, Maryland, United States
North Mississippi and Oncology Associates
Tupelo, Mississippi, United States
The Brookdale University Hospital and Medical Center
Brooklyn, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
East Chester Cancer Center
The Bronx, New York, United States
Waverly Hematology Oncology
Cary, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Charleston Hematology/Oncology Associates, P.A.
Charleston, South Carolina, United States
Carolina Blood and Cancer Care, PA
Rock Hill, South Carolina, United States
Westchase Clinical Associates
Houston, Texas, United States
Bon Secours St. Francis Medical Center
Midlothian, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1VIT14039
Identifier Type: -
Identifier Source: org_study_id
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