Trial Search Results
Efficacy and Safety of FG-4592 for Treatment of Anemia in Patients With Lower Risk MDS With Low Red Blood Cell Transfusion Burden
The purpose of this study is to find out if the experimental drugroxadustat (also known as FG-4592) is safe and effective forpotentially treating anemia in people with MDS.
Stanford is currently accepting patients for this trial.
Lead Sponsor:
FibroGen
Collaborator: AstraZeneca
Stanford Investigator(s):
Intervention(s):
- Drug: FG-4592
- Drug: Placebo
Phase:
Phase 3
Eligibility
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jinsuh Jung
650-497-6694
Recruiting