Status:
COMPLETED
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
Lead Sponsor:
FibroGen
Collaborating Sponsors:
AstraZeneca
Astellas Pharma Inc
Conditions:
Chemotherapy Induced Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This study consists of three periods: 1. Screening Period up to 28 days 2. Treatment Period of up to16 weeks 3. A Follow-up period of 4 weeks.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2021
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04076943
Start Date
August 20 2019
End Date
April 23 2021
Last Update
June 3 2022
Active Locations (15)
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1
Research Center
Los Alamitos, California, United States, 90720
2
Research Center
Los Angeles, California, United States, 90024
3
Research Center
Torrance, California, United States, 90505
4
Research Center
Jacksonville, Florida, United States, 32256