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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 : Recruiting
First Posted : September 4, 2019
Last Update Posted : September 3, 2020
Sponsor:
Collaborators:
AstraZeneca
Astellas Pharma Inc
Information provided by (Responsible Party):
FibroGen

Study Description
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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 people receiving chemotherapy treatment for cancer.

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Anemia Drug: Roxadustat (FG-4592) Phase 2

Detailed Description:

This study consists of three periods:

  1. Screening Period up to 28 days
  2. Treatment Period of 16 weeks
  3. A Follow-up period of 4 weeks.

A total of up to approximately 100 patients will be enrolled to receive roxadustat in an open-label manner.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 6, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Roxadustat (FG-4592) Drug: Roxadustat (FG-4592)
Roxadustat will be dosed orally three times a week.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum change in Hemoglobin within 16 weeks [ Time Frame: Baseline to Week 16 ]
    The primary efficacy endpoint is maximum change in hemoglobin within 16 weeks from baseline without RBC transfusion


Secondary Outcome Measures :
  1. Mean change in hemoglobin level [ Time Frame: Baseline to Week 16 ]
    Mean change in hemoglobin level from baseline to week 16 (without RBC transfusion)

  2. Change in hemoglobin [ Time Frame: Baseline to Week 16 ]
    Change in hemoglobin from baseline at Week 8, 12, 16 (without RBC transfusion)

  3. RBC transfusion [ Time Frame: Week 5 to Week 16 ]
    Number (%) of patients who had a RBC transfusion from beginning of Week 5 (Day 29)


Eligibility Criteria
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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 g/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. Patients with cancer receiving chemotherapy when the anticipated outcome is cure
  2. Patients who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy
  3. History of leukemia
  4. Patients who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment
  5. Any investigational drug within 8-weeks prior to treatment with roxadustat
  6. Anemia due to other etiologies
  7. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (e.g., deep vein thrombosis (DVT) or pulmonary embolism) within previous 6 months of screening
  8. Clinically significant or uncontrolled ongoing autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease, celiac disease, etc.)
  9. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
Contacts and Locations
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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


Contacts
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Contact: Gopal Saha (415) 978-1661 gsaha@Fibrogen.com
Contact: Charles Bradley (415) 978-1672 cbradley@Fibrogen.com

Locations
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United States, California
Research Center Recruiting
Los Alamitos, California, United States, 90720
Research Center Recruiting
Los Angeles, California, United States, 90024
Research Center Recruiting
Torrance, California, United States, 90505
United States, Florida
Research Center Recruiting
Jacksonville, Florida, United States, 32256
Research Center Recruiting
Plantation, Florida, United States, 33322
United States, Indiana
Research Center Recruiting
Fort Wayne, Indiana, United States, 46804
United States, Kentucky
Research Center Recruiting
Ashland, Kentucky, United States, 41101
United States, Louisiana
Research Center Recruiting
Covington, Louisiana, United States, 70433
United States, Maryland
Research Center Recruiting
Bethesda, Maryland, United States, 20817
United States, New Jersey
Research Center Recruiting
Livingston, New Jersey, United States, 07039
United States, New York
Research Center Recruiting
Bronx, New York, United States, 10469
Research Center Recruiting
Port Jefferson Station, New York, United States, 11776
United States, Ohio
Research Center Recruiting
Canton, Ohio, United States, 44718
United States, Pennsylvania
Research Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
FibroGen
AstraZeneca
Astellas Pharma Inc
More Information
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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
Last Update Posted: September 3, 2020
Last Verified: September 2020

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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