Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Sa… (NCT02453334) | Clinical Trial Compass
CompletedPhase 3
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
United States244 participantsStarted 2015-05-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18