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.
Brief Title
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cancer and Chemotherapy Related Anemia
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).
* 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).
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02453334
Org Class
Industry
Org Full Name
American Regent, Inc.
Org Study Id
1VIT14039
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
* 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.
Outcome Measure
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
Outcome Time Frame
Week 3 to Week 18
Secondary Outcomes
Outcome Description
Nonstudy Intervention is defined as any of the following:
* Initiation of erythropoietin for any reason
* Blood transfusion
* IV iron
* Prescribed use of oral iron
* Initiation of erythropoietin for any reason
* Blood transfusion
* IV iron
* Prescribed use of oral iron
Outcome Time Frame
Baseline to Week 18
Outcome Measure
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Outcome Description
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.
Outcome Time Frame
Baseline to Week 18
Outcome Measure
Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention
Outcome Description
Intervention is defined as any of the following:
* Initiation of erythropoietin for any reason
* Blood transfusion
* IV iron
* Prescribed use of oral iron
* Initiation of erythropoietin for any reason
* Blood transfusion
* IV iron
* Prescribed use of oral iron
Outcome Time Frame
Baseline to week 18
Outcome Measure
Percentage of Participants Who Received Nonstudy Intervention
Outcome Description
Intervention is defined as any of the following:
* Initiation of erythropoietin for any reason
* Blood transfusion
* IV iron
* Prescribed use of oral iron
* Initiation of erythropoietin for any reason
* Blood transfusion
* IV iron
* Prescribed use of oral iron
Outcome Time Frame
Baseline to week 18
Outcome Measure
Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
Outcome Description
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
Outcome Time Frame
Baseline to Week 18
Outcome Measure
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Outcome Description
Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.
Outcome Time Frame
Baseline to week 18
Outcome Measure
Percentage of Participants Requiring a Blood Transfusion
Outcome Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome Time Frame
Baseline to Day 7
Outcome Measure
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Outcome Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome Time Frame
Baseline to Week 2
Outcome Measure
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Outcome Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome Time Frame
Baseline to Week 3
Outcome Measure
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Outcome Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome Time Frame
Baseline to Week 6
Outcome Measure
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Outcome Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome Time Frame
Baseline to Week 9
Outcome Measure
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Outcome Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome Time Frame
Baseline to Week 12
Outcome Measure
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Outcome Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome Time Frame
Baseline to Week 15
Outcome Measure
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Outcome Description
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome Time Frame
Baseline to Week 18
Outcome Measure
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Outcome Description
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.
Outcome Time Frame
Baseline to Week 18
Outcome Measure
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Outcome Description
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.
Outcome Time Frame
From Baseline to Week 18
Outcome Measure
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Outcome Description
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.
Outcome Time Frame
Baseline to Week 18.
Outcome Measure
Correlation of Change in Hemoglobin With Baseline Hepcidin Level
Outcome Description
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.
Outcome Time Frame
Baseline to Week 18
Outcome Measure
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mark Chaitowitz
Investigator Email
machaito@montefiore.org
Investigator Phone
Categories Mesh Debug
Cancer --- NEOPLASMS
MeSH Terms
NEOPLASMS
FERRIC CARBOXYMALTOSE
SALINE SOLUTION
CRYSTALLOID SOLUTIONS
ISOTONIC SOLUTIONS
SOLUTIONS
PHARMACEUTICAL PREPARATIONS