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

FibroGen

Status and phase: Completed; Phase 2

Conditions: Chemotherapy Induced Anemia

Treatments: Drug: Roxadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT04076943

FGCL-4592-092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of non-myeloid malignancy
2. Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0 grams (g)/deciliter (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. Participants with cancer receiving chemotherapy when the anticipated outcome is cure
2. Participants who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy to treat/manage their cancer
3. History of leukemia
4. Participants who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment
5. Use of any investigational drug within 8-weeks prior to treatment with roxadustat
6. Clinically significant anemia due to other etiologies
7. 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
8. Clinically significant or uncontrolled ongoing autoimmune disease (for example, rheumatoid arthritis, Crohn's disease, celiac disease, etc.)
9. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

Roxadustat

Experimental group

Description:

Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks.

Treatment:

Drug: Roxadustat