A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
- Registration Number
- NCT05301517
- Lead Sponsor
- FibroGen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEPO® 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. Roxadustat 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.
- Primary Outcome Measures
Name Time Method Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13 Baseline, Weeks 9 through 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
Name Time Method 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 Chronic Illness Therapy-Fatigue (FACIT-F) Subscale Score Averaged Over Weeks 9-13 Baseline, Weeks 9 through 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 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 Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale Score Averaged Over Weeks 9-13 Baseline, Weeks 9 through 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 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 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
Trial Locations
- Locations (45)
Shandong First Medical University Cancer Hospital
🇨🇳Jinan, China
The Second Hospital of Lanzhou University
🇨🇳Lanzhou, China
Neijiang Second People's Hospital
🇨🇳Neijiang, China
The First Hospital of China Medical University - Oncology Department Breast Cancer Group
🇨🇳Shenyang, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Xuzhou Central Hospital
🇨🇳Xuzhou, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
The First People's Hospital of Foshan
🇨🇳Foshan, China
Jiangxi Cancer Hospital
🇨🇳Jiangxi, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, China
University of Science and Technology
🇨🇳Wuhan, China
Hunan Cancer Hospital
🇨🇳Changsha, China
The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)
🇨🇳Chongqing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Gynecologic Oncology Department
🇨🇳Guangzhou, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Jilin Cancer Hospital
🇨🇳Changchun, China
Deyang People's Hospital
🇨🇳Deyang, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Anhui Cancer Hospital
🇨🇳Hefei, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Oncology Department
🇨🇳Guangzhou, China
Hangzhou Cancer Hospital
🇨🇳Hangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, China
Wuhan Fourth Hospital
🇨🇳Wuhan, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Shanghai Chest Hospital
🇨🇳Shanghai, China
Shanghai Fifth People's Hospital
🇨🇳Shanghai, China
The First Hospital of China Medical University - Oncology Department Lung Cancer Group
🇨🇳Shenyang, China
Cancer Hospital of Xinjiang Medical University
🇨🇳Xinjiang, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China
Ningbo First Hospital
🇨🇳Ningbo, China
Peking University Cancer Hospital
🇨🇳Beijing, China
Capital Medical University Chest Hospital
🇨🇳Beijing, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, China
Sichuan Cancer Hospital
🇨🇳Chengdu, China
Chongqing Bishan People's Hospital
🇨🇳Chongqing, China
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, China
Jiangsu Province Hospital
🇨🇳Nanjing, China