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

  • STATUS
    Recruiting
  • End date
    May 12, 2023
  • participants needed
    146
  • sponsor
    FibroGen
Updated on 15 June 2022

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.

Details
Condition Chemotherapy Induced Anemia
Treatment Roxadustat, SEPO®
Clinical Study IdentifierNCT05301517
SponsorFibroGen
Last Modified on15 June 2022

Eligibility

Yes No Not Sure

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%

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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