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

Primary Purpose

Chemotherapy Induced Anemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Roxadustat
Sponsored by
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy Induced Anemia focused on measuring Anemia, Chemotherapy induced anemia, Myelosuppressive chemotherapy, Non-Myeloid malignances

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Center
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Roxadustat

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16

Full Information

First Posted
August 30, 2019
Last Updated
June 2, 2022
Sponsor
FibroGen
Collaborators
AstraZeneca, Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04076943
Brief Title
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
Collaborators
AstraZeneca, Astellas Pharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Screening Period up to 28 days Treatment Period of up to16 weeks A Follow-up period of 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Anemia
Keywords
Anemia, Chemotherapy induced anemia, Myelosuppressive chemotherapy, Non-Myeloid malignances

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roxadustat
Arm Type
Experimental
Arm Description
Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Roxadustat
Other Intervention Name(s)
FG-4592
Intervention Description
Roxadustat will be administered per schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion
Description
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.
Time Frame
Baseline, up to Week 16
Secondary Outcome Measure Information:
Title
Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)
Description
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.
Time Frame
Baseline, Week 16
Title
Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)
Description
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 Frame
Baseline, Weeks 9, 13, and 16
Title
Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16
Description
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.
Time Frame
Baseline through Week 16
Title
Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16
Description
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.
Time Frame
Baseline through Week 16
Title
Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16
Description
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.
Time Frame
Baseline through Week 16
Title
Percentage of Participants Who Achieved a Hematopoietic Response
Description
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.
Time Frame
Baseline through Week 16
Title
Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16
Description
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.
Time Frame
Baseline through Week 16
Title
Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16
Time Frame
Week 5 to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Center
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Research Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Research Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Research Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Facility Name
Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Research Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Research Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Research Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Research Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Research Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Facility Name
Research Center
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Research Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Research Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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