Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia

• Status: Completed
• Trial end date: 2021-04-23
• Target enrollment: 0
• Participant gender: All

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 people receiving chemotherapy treatment for cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen
• Collaborators: Astellas Pharma Inc; AstraZeneca
• Treatments: Glycine

Criteria

Inclusion Criteria:

1. Diagnosis of non-myeloid malignancy

2. Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0 g/dL at screening

3. Planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks

4. Estimated life expectancy ≥ 6 months at enrollment (Day 1)

Exclusion Criteria:

1. Patients with cancer receiving chemotherapy when the anticipated outcome is cure

2. Patients who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy

3. History of leukemia

4. Patients who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment

5. Any investigational drug within 8-weeks prior to treatment with roxadustat

6. Anemia due to other etiologies

7. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (e.g., deep vein thrombosis (DVT) or pulmonary embolism) within previous 6 months of screening

8. Clinically significant or uncontrolled ongoing autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease, celiac disease, etc.)

9. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection