Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
Cancer-Related Syndrome
Leukemia
Myelodysplastic Syndromes (MDS)
18 Years and older, Male and Female
FGCL-4592-082 (primary)
NCI-2017-02071
Summary
The purpose of this study is to determine whether FG-4592 is safe and effective in the
treatment of anemia in participants with lower risk MDS and low red blood cell
transfusion burden.
Objectives
This study includes an Open-Label Lead in, a Double-Blind component, and an Open-Label
High Erythropoietin component. There is a screening period of up to 42 days followed by a
treatment period of 52 weeks and a 4-week end of treatment assessment.
Eligibility
- Diagnosis of primary MDS classified by the International Prognostic Scoring System - Revised (IPSS-R) as very low, low or intermediate risk with <5% bone marrow blasts. There is no minimum time from diagnosis to registration/randomization except to allow for proper IPSS-R classification to be made (within 16 weeks prior to randomization), and to show transfusion dependence for participants in both portions of the study.
- RBC transfusion of either 2-4 pRBC units during the 8 weeks prior to registration/randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to registration/randomization. Open-Label Lead-in participants only, the requirement to demonstrate transfusion dependence can also be met by a Principal Investigator starting this particular participant on pRBC transfusion during the screening period.
- No restriction on prior use of recombinant erythropoietins or analogues (erythropoiesis-stimulating agents [ESAs]), except no ESA use within 8 weeks prior to Day 1 registration/randomization.
- Hemoglobin (Hb) =10.0 grams/deciliter (g/dL) during screening
- Eastern Cooperative Oncology Group (ECOG) of 0-2 at screening Key
Treatment Sites in Georgia
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