Chemotherapy Induced Anemia Clinical Trial
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
Verified date | June 2022 |
Source | FibroGen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | April 23, 2021 |
Est. primary completion date | March 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Research Center | Ashland | Kentucky |
United States | Research Center | Bethesda | Maryland |
United States | Research Center | Bronx | New York |
United States | Research Center | Canton | Ohio |
United States | Research Center | Covington | Louisiana |
United States | Research Center | Fort Wayne | Indiana |
United States | Research Center | Gettysburg | Pennsylvania |
United States | Research Center | Jacksonville | Florida |
United States | Research Center | Livingston | New Jersey |
United States | Research Center | Los Alamitos | California |
United States | Research Center | Los Angeles | California |
United States | Research Center | Philadelphia | Pennsylvania |
United States | Research Center | Plantation | Florida |
United States | Research Center | Port Jefferson Station | New York |
United States | Research Center | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
FibroGen | Astellas Pharma Inc, AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16 | Week 5 to Week 16 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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