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

Study Overview
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Brief Summary
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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
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This study consists of three periods: Screening Period up to 28 days Treatment Period of up to16 weeks A Follow-up period of 4 weeks.

Official Title
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A Phase 2 Open Label Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

Conditions
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Chemotherapy Induced Anemia

Intervention / Treatment
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* Drug: Roxadustat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roxadustat<br>Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks. | Drug: Roxadustat<br>* Roxadustat will be administered per schedule specified in the arm description.<br>* Other names: FG-4592;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion | Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. All central lab assessments from Day 1 to end of treatment (EOT) or early termination (ET) were included in the evaluation of this endpoint. Hb values within 4 weeks after an RBC transfusion were excluded. | Baseline, up to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion) | Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. Mean Hb during treatment was computed using the mean area-under-the-curve trapezoid method, from Day 1 to EOT or ET Hb assessment. | Baseline, Week 16 | 
| Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) | Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. | Baseline, Weeks 9, 13, and 16 | 
| Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16 | The 95% confidence interval (CI) was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded. | Baseline through Week 16 | 
| Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16 | Median was calculated using Kaplan-Meier product limit method. 95% CI was calculated using the method of Brookmeyer and Crowley. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion were excluded. | Baseline through Week 16 | 
| Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16 | The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded. | Baseline through Week 16 | 
| Percentage of Participants Who Achieved a Hematopoietic Response | Hematopoietic response was defined as an increase in Hb of 1.5 g/dL from baseline or attaining a Hb of 11 g/dL. The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded. | Baseline through Week 16 | 
| Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16 | The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded. | Baseline through Week 16 | 
| Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16 |  | Week 5 to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Chemotherapy induced anemia, Myelosuppressive chemotherapy, Non-Myeloid malignances