Phase 2
Completed N=92
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
Chemotherapy Induced Anemia
Source: ClinicalTrials.gov NCT04076943 ↗
Enrolled (actual)
92
Serious AEs
43.5%
Results posted
Jun 2022
Primary outcomePrimary: Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion — 2.47 g/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion |
2.47 | — |
| SECONDARY Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion) |
1.20 | — |
| SECONDARY Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) |
1.43; 2.15; 2.52 | — |
| SECONDARY Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16 |
82.0 | — |
| SECONDARY Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16 |
41.0 | — |
| SECONDARY Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16 |
73.0 | — |
| SECONDARY Percentage of Participants Who Achieved a Hematopoietic Response |
75.3 | — |
| SECONDARY Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16 |
60.7 | — |
| SECONDARY Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16 |
14.5 | — |
Eligibility Criteria
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
- 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.)
- Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
Data sourced from ClinicalTrials.gov (NCT04076943). 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.