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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roxadustat | Experimental | Participants will receive roxadustat, administered orally 3 times per week (TIW) for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be based on the participant's weight group. The maximum dose for individual participants may not exceed 3.5 milligrams (mg)/kilogram (kg) or 400 mg TIW whichever is lower. |
|
| SEPO® | Active Comparator | Participants will receive SEPO®, injected subcutaneously TIW for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be 150 international units (IU)/kg subcutaneously TIW. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEPO® | Drug | SEPO® will be administered per dose and schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Weeks 9 through 13 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Require Red Blood Cell (RBC) Transfusion or Hb <60 g/L or with any Hb< 60 g/L From Week 5 Through Week 13 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Hebei University | Baoding | China | ||||
| Cancer Hospital, Chinese Academy of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39353163 | Derived | 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. | |
| 36710399 |
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| Roxadustat | Drug | Roxadustat will be administered per dose and schedule specified in the arm description. |
|
|
| 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. | 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. | Baseline, Weeks 9 through 13 |
| 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 ≥ 15 g/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 |
| 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 |
| The First People's Hospital of Foshan | Foshan | China |
| Fujian Medical University Union Hospital | Fuzhou | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Gynecologic Oncology Department | Guangzhou | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Oncology Department | Guangzhou | China |
| Hangzhou Cancer Hospital | Hangzhou | China |
| Zhejiang Cancer Hospital | Hangzhou | China |
| Harbin Medical University Cancer Hospital | Harbin | China |
| Anhui Cancer Hospital | Hefei | China |
| Jiangxi Cancer Hospital | Jiangxi | China |
| Shandong First Medical University Cancer Hospital | Jinan | China |
| The Second Hospital of Lanzhou University | Lanzhou | China |
| Jiangsu Province Hospital | Nanjing | China |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | China |
| Neijiang Second People's Hospital | Neijiang | China |
| Ningbo First Hospital | Ningbo | China |
| Jiangxi Pingxiang People's Hospital | Pingxiang | China |
| The Affiliated Hospital of Qingdao University | Qingdao | China |
| Fudan University Shanghai Cancer Center | Shanghai | China |
| Shanghai Chest Hospital | Shanghai | China |
| Shanghai Fifth People's Hospital | Shanghai | China |
| Liaoning Cancer Hospital & Institute | Shenyang | China |
| The First Hospital of China Medical University - Oncology Department Breast Cancer Group | Shenyang | China |
| The First Hospital of China Medical University - Oncology Department Lung Cancer Group | Shenyang | China |
| Peking University Shenzhen Hospital | Shenzhen | China |
| Shanxi Cancer Hospital | Taiyuan | China |
| Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| University of Science and Technology | Wuhan | China |
| Wuhan Fourth Hospital | Wuhan | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| Cancer Hospital of Xinjiang Medical University | Xinjiang | China |
| Xuzhou Central Hospital | Xuzhou | China |
| Yantai Yuhuangding Hospital | Yantai | China |
| General Hospital of Ningxia Medical University | Yinchuan | China |
| Henan Cancer Hospital | Zhengzhou | China |
| Zhuzhou Central Hospital | Zhuzhou | China |
| 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. |
| ID | Term |
|---|---|
| C584543 | roxadustat |
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