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Completed

NCT Number: NCT04076943

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

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.

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Key information

Conditions

Chemotherapy Induced Anemia Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Center, Los Alamitos, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roxadustat

Drug

Roxadustat will be administered per schedule specified in the arm description.

Other names: FG-4592

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyntra Bio

Industry

Collaborators

  • Astellas Pharma Inc
  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2019
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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