Clinical trial NCT05301517: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy Induced Anemia
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13
timeFrame: Baseline, Weeks 9 through 13
Secondary outcomes:
measure: Percentage of Participants who Achieve a ≥10 Grams (g)/Liter (L) Increase in Hb From Baseline Through Week 13
timeFrame: Baseline through Week 13
measure: 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
timeFrame: Week 5 through Week 13
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale Score Averaged Over Weeks 9-13
timeFrame: Baseline, Weeks 9 through 13
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Subscale Score Averaged Over Weeks 9-13
timeFrame: Baseline, Weeks 9 through 13
measure: Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia
timeFrame: Baseline through Week 13
measure: Change in Hb From Baseline up to 4 Weeks After the Last Dose of Chemotherapy During the Treatment Period
timeFrame: Baseline up to 4 weeks after the last dose of chemotherapy (up to Week 16)
measure: Change in Hb From Baseline Through Week 9
timeFrame: Baseline through Week 9
measure: Change in Hb From Baseline Through Week 13
timeFrame: Baseline through Week 13
measure: Percentage of Participants who Achieve a ≥ 15 g/L Increase in Hb From Baseline Through Week 13
timeFrame: Baseline through Week 13
measure: Percentage of Participants who Achieve Hb Levels ≥ 110 g/L From Baseline Through Week 13
timeFrame: Baseline through Week 13
measure: 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
timeFrame: Baseline through Week 13
measure: Time to First RBC Transfusion
timeFrame: Baseline up to Week 13
measure: Percentage of Participants Requiring 1 or More RBC Transfusion
timeFrame: Baseline up to Week 13
measure: Number of RBC Transfusions Adjusted for Exposure From Baseline Through Week 13
timeFrame: Baseline through Week 13
measure: Percentage of Participants who Require RBC Transfusion as Medical Intervention and/or Erythropoiesis-Stimulating Agent (ESA) as a Rescue Agent
timeFrame: Baseline through Week 13
Other outcomes:
Locations:
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Capital Medical University Chest Hospital
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chongqing
country: China
facility: Chongqing Bishan People's Hospital
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)
city: Deyang
country: China
facility: Deyang People's Hospital
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Gynecologic Oncology Department
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Oncology Department
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: Anhui Cancer Hospital
city: Jiangxi
country: China
facility: Jiangxi Cancer Hospital
city: Jinan
country: China
facility: Shandong First Medical University Cancer Hospital
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
city: Neijiang
country: China
facility: Neijiang Second People's Hospital
city: Ningbo
country: China
facility: Ningbo First Hospital
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Shenyang
country: China
facility: The First Hospital of China Medical University - Oncology Department Breast Cancer Group
city: Shenyang
country: China
facility: The First Hospital of China Medical University - Oncology Department Lung Cancer Group
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: University of Science and Technology
city: Wuhan
country: China
facility: Wuhan Fourth Hospital
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xinjiang
country: China
facility: Cancer Hospital of Xinjiang Medical University
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
Study officials:
References: