A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
NCT ID: NCT05301517
Last Updated: 2023-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
159 participants
INTERVENTIONAL
2022-03-16
2023-04-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Roxadustat
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.
Roxadustat
Roxadustat will be administered per dose and schedule specified in the arm description.
SEPO®
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.
SEPO®
SEPO® will be administered per dose and schedule specified in the arm description.
Interventions
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SEPO®
SEPO® will be administered per dose and schedule specified in the arm description.
Roxadustat
Roxadustat will be administered per dose and schedule specified in the arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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%.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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FibroGen
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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References
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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.
Other Identifiers
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FGCL-4592-898
Identifier Type: -
Identifier Source: org_study_id
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