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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 4, 2019
Sponsor:
Collaborators:
AstraZeneca
Astellas Pharma Inc
Information provided by (Responsible Party):
FibroGen

Tracking Information
First Submitted Date  ICMJE August 30, 2019
First Posted Date  ICMJE September 4, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE August 6, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
  • Mean change in hemoglobin level [ Time Frame: Baseline to Week 16 ]
    Mean change in hemoglobin level from baseline to week 16 (without RBC transfusion)
  • Change in hemoglobin [ Time Frame: Baseline to Week 16 ]
    Change in hemoglobin from baseline through Week 8, 12, 16
  • RBC transfusion [ Time Frame: Baseline to end of study (Week 16) ]
    Number (%) of patients who had a RBC transfusion from baseline to end of study (week 16)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy Induced Anemia
Intervention  ICMJE Drug: Roxadustat (FG-4592)
Roxadustat will be dosed orally three times a week.
Study Arms  ICMJE Experimental: Roxadustat (FG-4592)
Intervention: Drug: Roxadustat (FG-4592)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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 screening
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gopal Saha (415) 978-1661 gsaha@Fibrogen.com
Contact: Charles Bradley (415) 978-1672 cbradley@Fibrogen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04076943
Other Study ID Numbers  ICMJE FGCL-4592-092
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FibroGen
Study Sponsor  ICMJE FibroGen
Collaborators  ICMJE
  • AstraZeneca
  • Astellas Pharma Inc
Investigators  ICMJE Not Provided
PRS Account FibroGen
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP