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

Chemotherapy Induced Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05301517
• Other study ID #: FGCL-4592-898
• Status: Completed
• Phase: Phase 3
• Start date: March 16, 2022
• Est. completion date: April 21, 2023

Study information

• Verified date: June 2023
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: April 21, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Chemotherapy Induced Anemia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants who Achieve a =10 Grams (g)/Liter (L) Increase in Hb From Baseline Through Week 13		Baseline through Week 13
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia		Baseline through Week 13
Secondary	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)
Secondary	Change in Hb From Baseline Through Week 9		Baseline through Week 9
Secondary	Change in Hb From Baseline Through Week 13		Baseline through Week 13
Secondary	Percentage of Participants who Achieve a = 15 g/L Increase in Hb From Baseline Through Week 13		Baseline through Week 13
Secondary	Percentage of Participants who Achieve Hb Levels = 110 g/L From Baseline Through Week 13		Baseline through Week 13
Secondary	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
Secondary	Time to First RBC Transfusion		Baseline up to Week 13
Secondary	Percentage of Participants Requiring 1 or More RBC Transfusion		Baseline up to Week 13
Secondary	Number of RBC Transfusions Adjusted for Exposure From Baseline Through Week 13		Baseline through Week 13
Secondary	Percentage of Participants who Require RBC Transfusion as Medical Intervention and/or Erythropoiesis-Stimulating Agent (ESA) as a Rescue Agent		Baseline through Week 13