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Trial record 1 of 1 for:    FGCL-4592-092
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Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia

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ClinicalTrials.gov Identifier: NCT04076943
Recruitment Status : Completed
First Posted : September 4, 2019
Results First Posted : June 3, 2022
Last Update Posted : June 3, 2022
Sponsor:
Collaborators:
AstraZeneca
Astellas Pharma Inc
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Anemia Drug: Roxadustat Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 20, 2019
Actual Primary Completion Date : March 26, 2021
Actual Study Completion Date : April 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

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 Name: FG-4592




Primary Outcome Measures :
  1. Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion [ Time Frame: 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 :
  1. Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion) [ Time Frame: 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.

  2. Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) [ Time Frame: 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.

  3. Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16 [ Time Frame: 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.

  4. Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16 [ Time Frame: 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.

  5. Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16 [ Time Frame: 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.

  6. Percentage of Participants Who Achieved a Hematopoietic Response [ Time Frame: 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.

  7. Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16 [ Time Frame: 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.

  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076943


Locations
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United States, California
Research Center
Los Alamitos, California, United States, 90720
Research Center
Los Angeles, California, United States, 90024
Research Center
Torrance, California, United States, 90505
United States, Florida
Research Center
Jacksonville, Florida, United States, 32256
Research Center
Plantation, Florida, United States, 33322
United States, Indiana
Research Center
Fort Wayne, Indiana, United States, 46804
United States, Kentucky
Research Center
Ashland, Kentucky, United States, 41101
United States, Louisiana
Research Center
Covington, Louisiana, United States, 70433
United States, Maryland
Research Center
Bethesda, Maryland, United States, 20817
United States, New Jersey
Research Center
Livingston, New Jersey, United States, 07039
United States, New York
Research Center
Bronx, New York, United States, 10469
Research Center
Port Jefferson Station, New York, United States, 11776
United States, Ohio
Research Center
Canton, Ohio, United States, 44718
United States, Pennsylvania
Research Center
Gettysburg, Pennsylvania, United States, 17325
Research Center
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
FibroGen
AstraZeneca
Astellas Pharma Inc
  Study Documents (Full-Text)

Documents provided by FibroGen:
Study Protocol  [PDF] May 22, 2020
Statistical Analysis Plan  [PDF] July 14, 2021

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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT04076943    
Other Study ID Numbers: FGCL-4592-092
First Posted: September 4, 2019    Key Record Dates
Results First Posted: June 3, 2022
Last Update Posted: June 3, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FibroGen:
Anemia
Chemotherapy induced anemia
Myelosuppressive chemotherapy
Non-Myeloid malignances
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases