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 not accepting patients for this trial.

Lead Sponsor:

FibroGen

Collaborator: AstraZeneca

Stanford Investigator(s):

Intervention(s):

  • Drug: Roxadustat
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Key Inclusion Criteria:

   - 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 Exclusion Criteria:

   - Diagnosis of secondary MDS associated with prior chemotherapy, extensive radiation
   therapy (>25% of bone marrow reserve), and or/other significant chemical or radiation
   exposure

   - Significant myelofibrosis (>2+ fibrosis)

   - MDS associated with 5q(del) cytogenetic abnormality

   - Screen serum erythropoietin level > 400 milli-international units (mIU)/milliliter
   (mL) • Clinically significant anemia, as determined by the investigator, due to
   non-MDS etiologies such as iron deficiency, vitamin B12 or folate deficiency,
   autoimmune or hereditary hemolysis or anemia or hemorrhage or hereditary anemia such
   as sickle cell anemia or thalassemia.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Robert Jones
650-497-6694
Not Recruiting