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Efficacy and Safety of FG-4592 for Treatment of Anemia in Patients With Lower Risk MDS With Low Red Blood Cell Transfusion Burden

Cancer Type
Cancer-Related Syndrome
Myelodysplastic Syndromes (MDS)
Trial Phase
Phase III
18 Years and older, Male and Female
Study Type
Protocol IDs
FGCL-4592-082 (primary)
Study Sponsor


The purpose of this study is to determine whether FG-4592 is safe and effective in the
treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood
Cell Transfusion Burden.


This study includes an Open-Label Lead in, a Double-Blind component and an Open-Label High
Erythropoietin component. In each, there is an up to 42 days screen period followed by a
treatment period of 52 weeks and a 4 week end of treatment assessment.


  1. Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts. There is no minimum time from diagnosis except to allow for proper IPSS-R classification to be made, and to show transfusion dependence.
  2. RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization
  3. No restriction on prior use of ESAs, except no ESA use within 8 weeks prior to registration/randomization
  4. Pre-transfusion hemoglobin of <= 10 g/dL,
  5. ECOG of 0-2 at screen
  6. History of cured malignancy with no evidence of recurrence for a least 3 years are eligible

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

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