Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia (NCT04076943) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
United States92 participantsStarted 2019-08-20
Plain-language summary
The purpose of this study is to find out if roxadustat (also known as FG-4592) is safe and effective for the treatment of anemia in participants receiving chemotherapy treatment for cancer.
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
. Diagnosis of non-myeloid malignancy
. Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0 grams (g)/deciliter (dL) at screening
. Planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks
. Estimated life expectancy ≥ 6 months at enrollment (Day 1)
Exclusion criteria
. Participants with cancer receiving chemotherapy when the anticipated outcome is cure
. Participants who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy to treat/manage their cancer
. History of leukemia
. Participants who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment
. Use of any investigational drug within 8-weeks prior to treatment with roxadustat
. Clinically significant anemia due to other etiologies
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
Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion
. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (for example, deep vein thrombosis \[DVT\] or pulmonary embolism) within previous 6 months of screening
. Clinically significant or uncontrolled ongoing autoimmune disease (for example, rheumatoid arthritis, Crohn's disease, celiac disease, etc.)