Phase 3
Completed N=244
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Cancer and Chemotherapy Related Anemia
Source: ClinicalTrials.gov NCT02453334 ↗
Enrolled (actual)
244
Serious AEs
20.9%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18 — 42; 60 Participants — p=0.0143
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18 |
42; 60 | 0.0143 sig |
| SECONDARY Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention |
9.63; 9.75; 0.27; 0.01; 0.53; 0.06 | — |
| SECONDARY Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention |
84; 64 | 0.0097 sig |
| SECONDARY Percentage of Participants Who Received Nonstudy Intervention |
22; 25 | 0.5758 |
| SECONDARY Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention |
31; 24 | 0.2772 |
| SECONDARY Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention |
15; 23; 43; 85; 106; NA | 0.0011 sig |
| SECONDARY Percentage of Participants Requiring a Blood Transfusion |
15; 14 | 0.8924 |
| SECONDARY Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit |
12; 9 | 0.6508 |
| SECONDARY Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. |
8; 12 | 0.2084 |
| SECONDARY Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 |
15; 14; 127; 43; NA; NA | 0.0063 sig |
| SECONDARY Correlation of Change in Hemoglobin With Baseline Hepcidin Level |
0.88; 1.13; 1.28; 0.02 | — |
| SECONDARY Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 |
21.8; 21.5; -0.8; -0.7; -0.3; 0.2 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02453334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.