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

Completed · Phase 3

Conditions studied: Cancer and Chemotherapy Related Anemia

In brief

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.

Key facts

Study ID

NCT02453334

Run by

American Regent, Inc.

People needed

244

Starts

2015-05-23

Expected to finish

2018-01-04

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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