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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

Sponsor
FibroGen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05301517
Collaborator
(none)
146
Enrollment
43
Locations
2
Arms
13.9
Anticipated Duration (Months)
3.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 16, 2022
Anticipated Primary Completion Date :
Apr 14, 2023
Anticipated Study Completion Date :
May 12, 2023

Arms and Interventions

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]

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Percentage of Participants who Achieve a ≥10 Grams (g)/Liter (L) Increase in Hb From Baseline Through Week 13 [Baseline through Week 13]

    2. Percentage of Participants who Require Red Blood Cell (RBC) Transfusion or Hb <60 g/L From Week 5 Through Week 13 [Week 5 through Week 13]

    3. 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.

    4. 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.

    5. Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia [Baseline through Week 13]

    6. 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)]

    7. Change in Hb From Baseline Through Week 9 [Baseline through Week 9]

    8. Change in Hb From Baseline Through Week 13 [Baseline through Week 13]

    9. Percentage of Participants who Achieve a ≥ 15 g/L Increase in Hb From Baseline Through Week 13 [Baseline through Week 13]

    10. Percentage of Participants who Achieve Hb Levels ≥ 110 g/L From Baseline Through Week 13 [Baseline through Week 13]

    11. 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]

    12. Time to First RBC Transfusion [Baseline up to Week 13]

    13. Percentage of Participants Requiring 1 or More RBC Transfusion [Baseline up to Week 13]

    14. Number of RBC Transfusions Adjusted for Exposure From Baseline Through Week 13 [Baseline through Week 13]

    15. Percentage of Participants who Require RBC Transfusion as Medical Intervention and/or Erythropoiesis-Stimulating Agent (ESA) as a Rescue Agent [Baseline through Week 13]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affiliated Hospital of Hebei University Baoding China
    2 Cancer Hospital, Chinese Academy of Medical Sciences Beijing China
    3 Capital Medical University Chest Hospital Beijing China
    4 Peking University Cancer Hospital Beijing China
    5 Jilin Cancer Hospital Changchun China
    6 Hunan Cancer Hospital Changsha China
    7 Sichuan Cancer Hospital Chengdu China
    8 Chongqing Bishan People's Hospital Chongqing China
    9 The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital) Chongqing China
    10 Deyang People's Hospital Deyang China
    11 The First People's Hospital of Foshan Foshan China
    12 Fujian Medical University Union Hospital Fuzhou China
    13 Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Gynecologic Oncology Department Guangzhou China
    14 Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Oncology Department Guangzhou China
    15 Hangzhou Cancer Hospital Hangzhou China
    16 Zhejiang Cancer Hospital Hangzhou China
    17 Harbin Medical University Cancer Hospital Harbin China
    18 Anhui Cancer Hospital Hefei China
    19 Jiangxi Cancer Hospital Jiangxi China
    20 Shandong First Medical University Cancer Hospital Jinan China
    21 The Second Hospital of Lanzhou University Lanzhou China
    22 Jiangsu Province Hospital Nanjing China
    23 Nanjing Drum Tower Hospital Nanjing China
    24 The People's Hospital of Guangxi Zhuang Autonomous Region Nanning China
    25 Neijiang Second People's Hospital Neijiang China
    26 The Affiliated Hospital of Qingdao University Qingdao China
    27 Fudan University Shanghai Cancer Center Shanghai China
    28 Shanghai Chest Hospital Shanghai China
    29 Shanghai Fifth People's Hospital Shanghai China
    30 Liaoning Cancer Hospital & Institute Shenyang China
    31 The First Hospital of China Medical University - Oncology Department Breast Cancer Group Shenyang China
    32 The First Hospital of China Medical University - Oncology Department Lung Cancer Group Shenyang China
    33 Peking University Shenzhen Hospital Shenzhen China
    34 Shanxi Cancer Hospital Taiyuan China
    35 Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Wuhan China
    36 The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an China
    37 Affiliated Hospital of Qinghai University Xining China
    38 Cancer Hospital of Xinjiang Medical University Xinjiang China
    39 Xuzhou Central Hospital Xuzhou China
    40 Yantai Yuhuangding Hospital Yantai China
    41 General Hospital of Ningxia Medical University Yinchuan China
    42 Henan Cancer Hospital Zhengzhou China
    43 Zhuzhou Central Hospital Zhuzhou China

    Sponsors and Collaborators

    • FibroGen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    FibroGen
    ClinicalTrials.gov Identifier:
    NCT05301517
    Other Study ID Numbers:
    • FGCL-4592-898
    First Posted:
    Mar 29, 2022
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anemia
    Epoetin Alfa

    Study Results

    No Results Posted as of Jun 3, 2022