drugset / Trial / NCT05301517
A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-03-16
- Primary completion
- 2023-04-03
- Completion
- 2023-04-21
Outcome
Met primary endpoint
paper the one-sided 97.5% CI for the treatment difference (‒3.4 g/L) was greater than the predefined noninferiority margin of ‒6.6 g/L, establishing noninferiority. PMID 39353163 ↗
paper Roxadustat was noninferior to rHuEPO-α in treating CIA in participants with nonmyeloid malignancies receiving multicycle treatments of myelosuppressive chemotherapy. PMID 39353163 ↗
Publications
- Lu S, Wu J, Jiang J, Guo Q, Yu Y, Liu Y, Zhang H, Qian L, Dai X, Xie Y, Fu T, Lee T, Lu Y, Ma R, Eisner MD. Efficacy and Safety of Roxadustat for Anemia in Patients Receiving Chemotherapy for Nonmyeloid Malignancies: A Randomized, Open-Label, Active-Controlled Phase III Study. J Clin Oncol. 2025 Jan 10;43(2):143-153. doi: 10.1200/JCO.23.02742. Epub 2024 Oct 1.
- Glaspy J, Gabrail NY, Locantore-Ford P, Lee T, Modelska K, Samal V, Henry DH. Open-label, Phase 2 study of roxadustat for the treatment of anemia in patients receiving chemotherapy for non-myeloid malignancies. Am J Hematol. 2023 May;98(5):703-711. doi: 10.1002/ajh.26865. Epub 2023 Feb 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Roxadustat | Small molecule | 100 mg | Oral |
| Subject | Roxadustat | Small molecule | 120 mg | Oral |
| Subject | Roxadustat | Small molecule | 150 mg | Oral |
| Comparator | SEPO® | Protein / enzyme biologic | 150 iu/kg | Subcutaneous |