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

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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy Induced Anemia
• Intervention / Treatment: Drug: Roxadustat

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Alamitos, California, United States, 90720
      • Research Center
    • Los Angeles, California, United States, 90024
      • Research Center
    • Torrance, California, United States, 90505
      • Research Center
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Research Center
    • Plantation, Florida, United States, 33322
      • Research Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Research Center
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Research Center
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Research Center
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Research Center
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Research Center
  • New York
    • Bronx, New York, United States, 10469
      • Research Center
    • Port Jefferson Station, New York, United States, 11776
      • Research Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Research Center
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Research Center
    • Philadelphia, Pennsylvania, United States, 19106
      • Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: FibroGen
• Collaborators: AstraZeneca; Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2019
• Primary Completion (ACTUAL): March 26, 2021
• Study Completion (ACTUAL): April 23, 2021

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (ACTUAL): September 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Anemia; Chemotherapy induced anemia; Myelosuppressive chemotherapy; Non-Myeloid malignances
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: FGCL-4592-092

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No