| Eligibility |
Inclusion Criteria:
1. Non-myeloid malignancy diagnosed by cytology/histology
2. Receiving and have received at least one cycle of drug therapy with a high
myelosuppressive adverse effect, including but not limited to chemotherapeutic agents
such as platinum, targeted agents, antibody-coupled drugs, immunosuppressive agents,
etc., and are expected to continue such therapy within 8 weeks of enrollment
3. ECOG score of 0-2 and an expected survival of 6 months or more.
4. Mean hemoglobin <10.0 g/dL at screening test and one follow-up test (at least one week
thereafter during the screening period), with a difference between the two tests of
=1.0 g/dL
5. Total bilirubin <1.5 x upper limit of normal (ULN) If Gilbert's syndrome (unconjugated
hyperbilirubinemia) have a total bilirubin < 3 x ULN.
6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN.
7. No iron deficiency, TSAT = 20% and ferritin = 100 ng/mL at screening.
8. Serum folate and vitamin B12 = lower limit of normal at screening.
9. eGFR >60 mL/min/1.73 at screening.
Exclusion Criteria:
1. Hematocrit (Hct) = 36 vol% at the screening assessment.
2. Prior history of leukemia.
3. Extensive bone metastases from breast cancer, head and neck cancer with combined whole
blood (trilineage) cytopenia, bone marrow invasion from lymphoma, definite brain
metastases (except for those whose symptoms have been controlled for =4 weeks) or bone
marrow metastases.
4. Combination of hereditary anemia, iron-granulocytic anemia, acute blood loss, active
bleeding (three consecutive positive fecal occult bloods or clinical judgment of the
investigator), hemolysis and other diseases that can cause anemia such as iron, folic
acid or vitamin B12 deficiency.
5. Active infection or inflammatory disease requiring systemic anti-infective therapy
within 1 week prior to the first dose, including concurrent autoimmune diseases with
inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid
arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.)
6. Concurrent retinal neovascularization requiring treatment (diabetic proliferative
retinopathy, age-related exudative macular degeneration, retinal vein occlusion,
macular edema, etc.)
7. Difficulty to take oral medications, or conditions that may have an impact on the
absorption of gastrointestinal medications such as a history of gastrectomy/bowel
resection or concomitant gastroparesis (excluding gastric polyps or colonic
polypectomy).
8. clinically significant bleeding (including the need for blood transfusion or a
decrease in hemoglobin = 2 g/dL) within 4 weeks prior to the first dose, or a bleeding
constitutional or bleeding risk that has not been medically or surgically corrected.
9. Uncontrolled hypertension (more than one-third of identifiable diastolic blood
pressure values > 90 mmHg and/or systolic blood pressure = 160 mmHg at 16 weeks prior
to and including screening testing)
10. Concurrent congestive heart failure (New York Heart Association [NYHA] class III or
higher).
11. Clinically significant ECG abnormalities at the time of screening evaluation
12. Medical history of significant liver disease or active liver disease
13. History of stroke, transient ischemic attack (TIA), myocardial infarction,
thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or pulmonary
infarction within 24 weeks prior to the screening evaluation
14. History of prior thrombosis, significant coagulation abnormalities, history of
hematologic disease, or history of ineffective erythropoietin therapy
15. History of epilepsy or any past seizures.
16. Positive hepatitis B surface antigen (HBsAg), or positive anti-hepatitis C virus (HCV)
antibodies, or positive human immunodeficiency virus HIV at screening evaluation.
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