A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

NCT05301517 | Completed Phase 3 DMC

• 1 other identifier: FGCL-4592-898
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 45

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.

Conditions

Chemotherapy Induced Anemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• 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

  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

• 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

• Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia

  Baseline through Week 13

Study Arms (2)

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.

Drug: Roxadustat

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.

Drug: SEPO®

Interventions

SEPO® DRUG

SEPO® will be administered per dose and schedule specified in the arm description.

Also known as: Recombinant human erythropoietin-α [rHuEPO-α]

SEPO®

Roxadustat DRUG

Roxadustat will be administered per dose and schedule specified in the arm description.

Also known as: FG-4592

Roxadustat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyntra Bio: lead

Study Sites (45)

Affiliated Hospital of Hebei University

Baoding, China

Location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Capital Medical University Chest Hospital

Beijing, China

Location

Peking University Cancer Hospital

Beijing, China

Location

Jilin Cancer Hospital

Changchun, China

Location

Hunan Cancer Hospital

Changsha, China

Location

Sichuan Cancer Hospital

Chengdu, China

Location

Chongqing Bishan People's Hospital

Chongqing, China

Location

The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)

Chongqing, China

Location

Deyang People's Hospital

Deyang, China

Location

The First People's Hospital of Foshan

Foshan, China

Location

Fujian Medical University Union Hospital

Fuzhou, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Gynecologic Oncology Department

Guangzhou, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Oncology Department

Guangzhou, China

Location

Hangzhou Cancer Hospital

Hangzhou, China

Location

Zhejiang Cancer Hospital

Hangzhou, China

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

Anhui Cancer Hospital

Hefei, China

Location

Jiangxi Cancer Hospital

Jiangxi, China

Location

Shandong First Medical University Cancer Hospital

Jinan, China

Location

The Second Hospital of Lanzhou University

Lanzhou, China

Location

Jiangsu Province Hospital

Nanjing, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

Location

Neijiang Second People's Hospital

Neijiang, China

Location

Ningbo First Hospital

Ningbo, China

Location

Jiangxi Pingxiang People's Hospital

Pingxiang, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

Shanghai Fifth People's Hospital

Shanghai, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, China

Location

The First Hospital of China Medical University - Oncology Department Breast Cancer Group

Shenyang, China

Location

The First Hospital of China Medical University - Oncology Department Lung Cancer Group

Shenyang, China

Location

Peking University Shenzhen Hospital

Shenzhen, China

Location

Shanxi Cancer Hospital

Taiyuan, China

Location

Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

University of Science and Technology

Wuhan, China

Location

Wuhan Fourth Hospital

Wuhan, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

Cancer Hospital of Xinjiang Medical University

Xinjiang, China

Location

Xuzhou Central Hospital

Xuzhou, China

Location

Yantai Yuhuangding Hospital

Yantai, China

Location

General Hospital of Ningxia Medical University

Yinchuan, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

Zhuzhou Central Hospital

Zhuzhou, China

Location

Related Publications (2)

• 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.

  PMID: 39353163 DERIVED

• 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.

  PMID: 36710399 DERIVED

MeSH Terms

Interventions

roxadustat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: March 29, 2022
• Study Start: March 16, 2022
• Primary Completion: April 3, 2023
• Study Completion: April 21, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (45)