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

A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of Roxadustat for Treatment of Anemia in Subjects Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy Induced Anemia
• Intervention / Treatment: Drug: Roxadustat; Drug: SEPO®

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Baoding, China
    • Affiliated Hospital of Hebei University
  • Beijing, China
    • Cancer Hospital, Chinese Academy of Medical Sciences
  • Beijing, China
    • Peking University Cancer Hospital
  • Beijing, China
    • Capital Medical University Chest Hospital
  • Changchun, China
    • Jilin Cancer Hospital
  • Changsha, China
    • Hunan Cancer Hospital
  • Chengdu, China
    • Sichuan Cancer Hospital
  • Chongqing, China
    • Chongqing Bishan People's Hospital
  • Chongqing, China
    • The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)
  • Deyang, China
    • Deyang People's Hospital
  • Foshan, China
    • The First People's Hospital of Foshan
  • Fuzhou, China
    • Fujian Medical University Union Hospital
  • Guangzhou, 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
  • Hangzhou, China
    • Zhejiang Cancer Hospital
  • Hangzhou, China
    • Hangzhou Cancer Hospital
  • Harbin, China
    • Harbin Medical University Cancer Hospital
  • Hefei, China
    • Anhui Cancer Hospital
  • Jiangxi, China
    • Jiangxi Cancer Hospital
  • Jinan, China
    • Shandong First Medical University Cancer Hospital
  • Lanzhou, China
    • The Second Hospital of Lanzhou University
  • Nanjing, China
    • Jiangsu Province Hospital
  • Nanning, China
    • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Neijiang, China
    • Neijiang Second People's Hospital
  • Ningbo, China
    • Ningbo First Hospital
  • Pingxiang, China
    • Jiangxi Pingxiang People's Hospital
  • Qingdao, China
    • The Affiliated Hospital of Qingdao University
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
  • Shanghai, China
    • Shanghai Chest Hospital
  • Shanghai, China
    • Shanghai Fifth People's Hospital
  • Shenyang, 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
  • Shenzhen, China
    • Peking University Shenzhen Hospital
  • Taiyuan, China
    • Shanxi Cancer hospital
  • Wuhan, China
    • Union Hospital Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan, China
    • University of Science and Technology
  • Wuhan, China
    • Wuhan Fourth Hospital
  • Xi'an, China
    • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Xinjiang, China
    • Cancer Hospital of Xinjiang Medical University
  • Xuzhou, China
    • Xuzhou Central Hospital
  • Yantai, China
    • Yantai Yuhuangding Hospital
  • Yinchuan, China
    • General Hospital of Ningxia Medical University
  • Zhengzhou, China
    • Henan Cancer Hospital
  • Zhuzhou, China
    • ZhuZhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Roxadustat; Roxadustat will be administered per dose and schedule specified in the arm description.; Other Names: FG-4592
Active Comparator: 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.	Drug: SEPO®; SEPO® will be administered per dose and schedule specified in the arm description.; Other Names: Recombinant human erythropoietin-α [rHuEPO-α]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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
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

Collaborators and Investigators

• Sponsor: FibroGen

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): April 3, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: March 19, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: FGCL-4592-898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No