Clinical trial NCT02453334: Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer and Chemotherapy Related Anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
timeFrame: Week 3 to Week 18
Secondary outcomes:
measure: Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
timeFrame: Baseline to Week 18
measure: Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention
timeFrame: Baseline to Week 18
measure: Percentage of Participants Who Received Nonstudy Intervention
timeFrame: Baseline to week 18
measure: Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
timeFrame: Baseline to week 18
measure: Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
timeFrame: Baseline to Week 18
measure: Percentage of Participants Requiring a Blood Transfusion
timeFrame: Baseline to week 18
measure: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
timeFrame: Baseline to Day 7
measure: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
timeFrame: Baseline to Week 2
measure: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
timeFrame: Baseline to Week 3
measure: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
timeFrame: Baseline to Week 6
measure: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
timeFrame: Baseline to Week 9
measure: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
timeFrame: Baseline to Week 12
measure: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
timeFrame: Baseline to Week 15
measure: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
timeFrame: Baseline to Week 18
measure: Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
timeFrame: Baseline to Week 18
measure: Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
timeFrame: From Baseline to Week 18
measure: Correlation of Change in Hemoglobin With Baseline Hepcidin Level
timeFrame: Baseline to Week 18.
measure: Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
timeFrame: Baseline to Week 18
Other outcomes:
Locations:
city: Corona
country: United States
facility: Compassionate Care Research Group, Inc.
state: California
city: Fountain Valley
country: United States
facility: Compassionate Care Research Group, Inc.
state: California
city: Riverside
country: United States
facility: Compassionate Care Research Group, Inc.
state: California
city: Boynton Beach
country: United States
facility: University Cancer Institute
state: Florida
city: Miami Lakes
country: United States
facility: AR Development Solutions
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Winter Haven
country: United States
facility: Bond Bond Clinic, P.A.
state: Florida
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates
state: Illinois
city: Normal
country: United States
facility: MId-Illinois Hematology & Oncology Associates, Ltd.
state: Illinois
city: Rockford
country: United States
facility: OSF Saint Anthony Medical Center for Cancer Care
state: Illinois
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc.
state: Indiana
city: South Bend
country: United States
facility: Michiana Hematology Oncology, PC
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Ashland
country: United States
facility: Ashland-Bellefonte Cancer Center
state: Kentucky
city: Bethesda
country: United States
facility: Rcca Md, Llc
state: Maryland
city: Hagerstown
country: United States
facility: Antietam Oncology and Hematology Group, P.C.
state: Maryland
city: Tupelo
country: United States
facility: North Mississippi and Oncology Associates
state: Mississippi
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Bronx
country: United States
facility: East Chester Cancer Center
state: New York
city: Brooklyn
country: United States
facility: The Brookdale University Hospital and Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Cary
country: United States
facility: Waverly Hematology Oncology
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialists
state: North Carolina
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology/Oncology Associates, P.A.
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care, PA
state: South Carolina
city: Houston
country: United States
facility: Westchase Clinical Associates
state: Texas
city: Midlothian
country: United States
facility: Bon Secours St. Francis Medical Center
state: Virginia
Study officials:
References: