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

Chemotherapy Induced Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076943
• Other study ID #: FGCL-4592-092
• Status: Completed
• Phase: Phase 2
• Start date: August 20, 2019
• Est. completion date: April 23, 2021

Study information

• Verified date: June 2022
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 23, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Chemotherapy Induced Anemia

Intervention

Drug:
• Roxadustat
Roxadustat will be administered per schedule specified in the arm description.

Locations

Country	Name	City	State
United States	Research Center	Ashland	Kentucky
United States	Research Center	Bethesda	Maryland
United States	Research Center	Bronx	New York
United States	Research Center	Canton	Ohio
United States	Research Center	Covington	Louisiana
United States	Research Center	Fort Wayne	Indiana
United States	Research Center	Gettysburg	Pennsylvania
United States	Research Center	Jacksonville	Florida
United States	Research Center	Livingston	New Jersey
United States	Research Center	Los Alamitos	California
United States	Research Center	Los Angeles	California
United States	Research Center	Philadelphia	Pennsylvania
United States	Research Center	Plantation	Florida
United States	Research Center	Port Jefferson Station	New York
United States	Research Center	Torrance	California

Sponsors (3)

Lead Sponsor	Collaborator
FibroGen	Astellas Pharma Inc, AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16		Week 5 to Week 16