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

Primary Purpose

Chemotherapy Induced Anemia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SEPO®
Roxadustat
Sponsored by
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy Induced Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of non-myeloid malignancy, by histological or cytological confirmation with non-curative intent.
  • 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.

Sites / Locations

  • Affiliated Hospital of Hebei University
  • Cancer Hospital, Chinese Academy of Medical Sciences
  • Capital Medical University Chest Hospital
  • Peking University Cancer Hospital
  • Jilin Cancer Hospital
  • Hunan Cancer Hospital
  • Sichuan Cancer Hospital
  • Chongqing Bishan People's Hospital
  • The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)
  • Deyang People's Hospital
  • The First People's Hospital of Foshan
  • Fujian Medical University Union Hospital
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Gynecologic Oncology Department
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Oncology Department
  • Hangzhou Cancer Hospital
  • Zhejiang Cancer Hospital
  • Harbin Medical University Cancer Hospital
  • Anhui Cancer Hospital
  • Jiangxi Cancer Hospital
  • Shandong First Medical University Cancer Hospital
  • The Second Hospital of Lanzhou University
  • Jiangsu Province Hospital
  • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Neijiang Second People's Hospital
  • Ningbo First Hospital
  • Jiangxi Pingxiang People's Hospital
  • The Affiliated Hospital of Qingdao University
  • Fudan University Shanghai Cancer Center
  • Shanghai Chest Hospital
  • Shanghai Fifth People's Hospital
  • Liaoning Cancer Hospital & Institute
  • The First Hospital of China Medical University - Oncology Department Breast Cancer Group
  • The First Hospital of China Medical University - Oncology Department Lung Cancer Group
  • Peking University Shenzhen Hospital
  • Shanxi Cancer Hospital
  • Union Hospital Tongji Medical College, Huazhong University of Science and Technology
  • University of Science and Technology
  • Wuhan Fourth Hospital
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Cancer Hospital of Xinjiang Medical University
  • Xuzhou Central Hospital
  • Yantai Yuhuangding Hospital
  • General Hospital of Ningxia Medical University
  • Henan Cancer Hospital
  • Zhuzhou Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Roxadustat

SEPO®

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants who Achieve a ≥10 Grams (g)/Liter (L) Increase in Hb From 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
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.
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.
Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia
Change in Hb From Baseline up to 4 Weeks After the Last Dose of Chemotherapy During the Treatment Period
Change in Hb From Baseline Through Week 9
Change in Hb From Baseline Through Week 13
Percentage of Participants who Achieve a ≥ 15 g/L Increase in Hb From Baseline Through Week 13
Percentage of Participants who Achieve Hb Levels ≥ 110 g/L From 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
Time to First RBC Transfusion
Percentage of Participants Requiring 1 or More RBC Transfusion
Number of RBC Transfusions Adjusted for Exposure From Baseline Through Week 13
Percentage of Participants who Require RBC Transfusion as Medical Intervention and/or Erythropoiesis-Stimulating Agent (ESA) as a Rescue Agent

Full Information

First Posted
March 19, 2022
Last Updated
June 5, 2023
Sponsor
FibroGen
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1. Study Identification

Unique Protocol Identification Number
NCT05301517
Brief Title
A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
April 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roxadustat
Arm Type
Experimental
Arm Description
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.
Arm Title
SEPO®
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SEPO®
Other Intervention Name(s)
Recombinant human erythropoietin-α [rHuEPO-α]
Intervention Description
SEPO® will be administered per dose and schedule specified in the arm description.
Intervention Type
Drug
Intervention Name(s)
Roxadustat
Other Intervention Name(s)
FG-4592
Intervention Description
Roxadustat will be administered per dose and schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13
Description
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.
Time Frame
Baseline, Weeks 9 through 13
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve a ≥10 Grams (g)/Liter (L) Increase in Hb From Baseline Through Week 13
Time Frame
Baseline through Week 13
Title
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
Time Frame
Week 5 through Week 13
Title
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale Score Averaged Over Weeks 9-13
Description
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.
Time Frame
Baseline, Weeks 9 through 13
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Subscale Score Averaged Over Weeks 9-13
Description
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.
Time Frame
Baseline, Weeks 9 through 13
Title
Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia
Time Frame
Baseline through Week 13
Title
Change in Hb From Baseline up to 4 Weeks After the Last Dose of Chemotherapy During the Treatment Period
Time Frame
Baseline up to 4 weeks after the last dose of chemotherapy (up to Week 16)
Title
Change in Hb From Baseline Through Week 9
Time Frame
Baseline through Week 9
Title
Change in Hb From Baseline Through Week 13
Time Frame
Baseline through Week 13
Title
Percentage of Participants who Achieve a ≥ 15 g/L Increase in Hb From Baseline Through Week 13
Time Frame
Baseline through Week 13
Title
Percentage of Participants who Achieve Hb Levels ≥ 110 g/L From Baseline Through Week 13
Time Frame
Baseline through Week 13
Title
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
Time Frame
Baseline through Week 13
Title
Time to First RBC Transfusion
Time Frame
Baseline up to Week 13
Title
Percentage of Participants Requiring 1 or More RBC Transfusion
Time Frame
Baseline up to Week 13
Title
Number of RBC Transfusions Adjusted for Exposure From Baseline Through Week 13
Time Frame
Baseline through Week 13
Title
Percentage of Participants who Require RBC Transfusion as Medical Intervention and/or Erythropoiesis-Stimulating Agent (ESA) as a Rescue Agent
Time Frame
Baseline through Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
Country
China
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
Capital Medical University Chest Hospital
City
Beijing
Country
China
Facility Name
Peking University Cancer Hospital
City
Beijing
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Facility Name
Sichuan Cancer Hospital
City
Chengdu
Country
China
Facility Name
Chongqing Bishan People's Hospital
City
Chongqing
Country
China
Facility Name
The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)
City
Chongqing
Country
China
Facility Name
Deyang People's Hospital
City
Deyang
Country
China
Facility Name
The First People's Hospital of Foshan
City
Foshan
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Gynecologic Oncology Department
City
Guangzhou
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Oncology Department
City
Guangzhou
Country
China
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
Country
China
Facility Name
Anhui Cancer Hospital
City
Hefei
Country
China
Facility Name
Jiangxi Cancer Hospital
City
Jiangxi
Country
China
Facility Name
Shandong First Medical University Cancer Hospital
City
Jinan
Country
China
Facility Name
The Second Hospital of Lanzhou University
City
Lanzhou
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
Country
China
Facility Name
Neijiang Second People's Hospital
City
Neijiang
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Fifth People's Hospital
City
Shanghai
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
Country
China
Facility Name
The First Hospital of China Medical University - Oncology Department Breast Cancer Group
City
Shenyang
Country
China
Facility Name
The First Hospital of China Medical University - Oncology Department Lung Cancer Group
City
Shenyang
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
Country
China
Facility Name
Shanxi Cancer Hospital
City
Taiyuan
Country
China
Facility Name
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
University of Science and Technology
City
Wuhan
Country
China
Facility Name
Wuhan Fourth Hospital
City
Wuhan
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Name
Cancer Hospital of Xinjiang Medical University
City
Xinjiang
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Facility Name
Zhuzhou Central Hospital
City
Zhuzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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