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Phase 2 study of Roxadustat for Treatment of Anemia

A Phase 2 Open Label Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

  • Clinical Trial Information

    Trial Contact: Donaldson, Karin M; Valdez, Crystal

    Trial Phone: 321.841.9821 ; 321.841.6626

  • IRB No: 1280533

    Protocol Abbrev: TRIO FGCL-4592-092

    Principal Investigator: Julio J. Hajdenberg, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: FGCL-4592-092

    Treatment: All patients will receive roxadustat

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT04076943

  • Objective

    The purpose of this study is to find out if roxadustat (also known as FG-4592) is safe and effective for the treatment of anemia in people receiving chemotherapy treatment for cancer.

  • Key Eligibility

    1.Diagnosis of non-myeloid malignancy
    2.Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0 g/dL at screening
    3.Planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks