Chemotherapy Induced Anemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSEPO®
SEPO® will be administered per dose and schedule specified in the arm description.
DRUGRoxadustat
Roxadustat will be administered per dose and schedule specified in the arm description.
Sponsors
FibroGen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of non-myeloid malignancy, by histological or cytological confirmation. * Anemia related to myelosuppressive chemotherapy, defined as Hb ≤100 g/L at screening with documented participant's Hb level decrease ≥10 g/L after the initiation of chemotherapy as judged by the investigator. * Planned concurrent treatment of cancer (myelosuppressive chemotherapy) for at least 8 additional weeks. * Body weight ≥40 kg. * Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 2. * Ferritin ≥50 nanograms (ng)/milliliter (mL) and transferrin saturation (TSAT) ≥10%. Key
Exclusion criteria
* Participants with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. * Participants who are only receiving hormonal products, biological products, novel immunosuppressive products (such as programmed cell death protein-1 \[PD-1\] and programmed death-ligand 1 \[PD-L1\] checkpoint inhibitors) or targeted biological or radiation therapy to treat/manage their cancer, however if chemotherapy is co-administered with these products, then it is acceptable to enroll the participant. * Participants with hematocrit (HCT) ≥36%. * Participants who have received an RBC transfusion or ESA within 4 weeks of randomization. * Thromboembolic event (including but not limited to deep vein thrombosis \[DVT\], pulmonary embolism, myocardial infarction, stroke, transient ischemic attack \[TIA\] within previous 6 months of screening. * Clinically significant anemia due to other etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, or hereditary anemia such as sickle cell anemia or thalassemia. * The Investigator judges that the participant will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical conditions. Note: Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13 | Baseline, Weeks 9 through 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 5 through Week 13 | — |
| Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale Score Averaged Over Weeks 9-13 | Baseline, Weeks 9 through 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. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Subscale Score Averaged Over Weeks 9-13 | Baseline, Weeks 9 through 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. |
| Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia | Baseline through Week 13 | — |
| Change in Hb From Baseline up to 4 Weeks After the Last Dose of Chemotherapy During the Treatment Period | Baseline up to 4 weeks after the last dose of chemotherapy (up to Week 16) | — |
| Change in Hb From Baseline Through Week 9 | Baseline through Week 9 | — |
| Change in Hb From Baseline Through Week 13 | Baseline through Week 13 | — |
| Percentage of Participants who Achieve a ≥10 Grams (g)/Liter (L) Increase in Hb From Baseline Through Week 13 | Baseline through Week 13 | — |
| Percentage of Participants who Achieve Hb Levels ≥ 110 g/L From Baseline Through Week 13 | 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 | Baseline through Week 13 | — |
| Time to First RBC Transfusion | Baseline up to Week 13 | — |
| Percentage of Participants Requiring 1 or More RBC Transfusion | Baseline up to Week 13 | — |
| Number of RBC Transfusions Adjusted for Exposure From Baseline Through Week 13 | Baseline through Week 13 | — |
| Percentage of Participants who Require RBC Transfusion as Medical Intervention and/or Erythropoiesis-Stimulating Agent (ESA) as a Rescue Agent | Baseline through Week 13 | — |
| Percentage of Participants who Achieve a ≥ 15 g/L Increase in Hb From Baseline Through Week 13 | Baseline through Week 13 | — |
Countries
China
Outcome results
None listed