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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen
• Collaborators: Astellas Pharma Inc; AstraZeneca

Criteria

Key Inclusion Criteria:

• 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.

• 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

• No restriction on prior use of ESAs, except no ESA use within 8 weeks prior to registration/randomization

• Pre-transfusion hemoglobin of <= 10 g/dL,

• ECOG of 0-2 at screen

• History of cured malignancy with no evidence of recurrence for a least 3 years are eligible

Key Exclusion Criteria:

• Diagnosis of secondary MDS

• Significant myelofibrosis (>2+fibrosis)

• MDS associated with 5q(del) abnormality

• Screen serum erythropoietin level > 400 mIU/mL (Double Blind); for Open- Label High Erythropoietin patients serum erythropoietin level must be >400 mIU/mL

• Clinically significant anemia due to non-MDS etiologies