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

Phase 2

Completed

• Conditions: Chemotherapy Induced Anemia
• Interventions: Drug: Roxadustat

• Registration Number: NCT04076943
• Lead Sponsor: FibroGen

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.

Study Timeline

• Study Start: 2019-08-20
• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-04
• Primary Completion: 2021-03-26
• Study Completion: 2021-04-23
• Results First Submitted: 2022-05-10
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Results First Posted: 2022-06-03
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion	Baseline, up to Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)	Baseline, Week 16	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.
Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16	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.
Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16	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.
Percentage of Participants Who Achieved a Hematopoietic Response	Baseline through Week 16	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.
Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16	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.
Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)	Baseline, Weeks 9, 13, and 16	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.
Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16	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.
Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16	Week 5 to Week 16

Trial Locations

Locations (1)

Research Center; 🇺🇸 Philadelphia, Pennsylvania, United States