The main goal of this study is to evaluate the efficacy of roxadustat for treatment of anemia in participants with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy.
Participants who are eligible for participation will be randomized to roxadustat and SEPO® (recombinant human erythropoietin-α \[rHuEPO-α\]), and undergo a 12-week treatment period followed by a 4-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
SEPO® will be administered per dose and schedule specified in the arm description.
Roxadustat will be administered per dose and schedule specified in the arm description.
Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13
Hb levels measured from Weeks 9 through 13 will be averaged in order to provide a single measure for comparison to the baseline Hb levels.
Time frame: Baseline, Weeks 9 through 13
Percentage of Participants who Achieve a ≥10 Grams (g)/Liter (L) Increase in Hb From Baseline Through Week 13
Time frame: Baseline through Week 13
Percentage of Participants who Require Red Blood Cell (RBC) Transfusion or Hb <60 g/L or with any Hb< 60 g/L From Week 5 Through Week 13
Time frame: Week 5 through Week 13
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale Score Averaged Over Weeks 9-13
FACT-An subscale scores will be averaged over Weeks 9 through 13 in order to provide a single measure for comparison to the baseline score.
Time frame: Baseline, Weeks 9 through 13
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Subscale Score Averaged Over Weeks 9-13
FACIT-F subscale scores will be averaged over Weeks 9 through 13 in order to provide a single measure for comparison to the baseline score.
Time frame: Baseline, Weeks 9 through 13
Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia
Time frame: Baseline through Week 13
Change in Hb From Baseline up to 4 Weeks After the Last Dose of Chemotherapy During the Treatment Period
Time frame: Baseline up to 4 weeks after the last dose of chemotherapy (up to Week 16)
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Affiliated Hospital of Hebei University
Baoding, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Capital Medical University Chest Hospital
Beijing, China
Peking University Cancer Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
Hunan Cancer Hospital
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
Chongqing Bishan People's Hospital
Chongqing, China
The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)
Chongqing, China
Deyang People's Hospital
Deyang, China
...and 35 more locations
Change in Hb From Baseline Through Week 9
Time frame: Baseline through Week 9
Change in Hb From Baseline Through Week 13
Time frame: Baseline through Week 13
Percentage of Participants who Achieve a ≥ 15 g/L Increase in Hb From Baseline Through Week 13
Time frame: Baseline through Week 13
Percentage of Participants who Achieve Hb Levels ≥ 110 g/L From Baseline Through Week 13
Time frame: Baseline through Week 13
Percentage of Participants who Achieve an Increase in Hb of 15 g/L or Attaining a Hb of 110 g/L From Baseline Through Week 13
Time frame: Baseline through Week 13
Time to First RBC Transfusion
Time frame: Baseline up to Week 13
Percentage of Participants Requiring 1 or More RBC Transfusion
Time frame: Baseline up to Week 13
Number of RBC Transfusions Adjusted for Exposure From Baseline Through Week 13
Time frame: Baseline through Week 13
Percentage of Participants who Require RBC Transfusion as Medical Intervention and/or Erythropoiesis-Stimulating Agent (ESA) as a Rescue Agent
Time frame: Baseline through Week 13