About this trial
The purpose of this study is to determine the safety and efficacy of various doses of AND017 after 6 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.
Eligibility criteria
Qualifiers
Non-myeloid malignancy diagnosed by cytology/histology.
ECOG score 0-2 and expected survival of 6 months or more.
The mean value of hemoglobin at screening test and one follow-up test (more than one week between tests) was <10.0 g/dL, with a difference of ≤1.0 g/dL between the two tests.
Adequate hepatic and renal function.
Disqualifiers
Received chemotherapy, radiotherapy, and other, e.g., immunosuppressive, targeted drug therapy that has a suppressive effect on the bone marrow within 1 month prior to randomization or planned during the trial.
A medical history of significant liver disease or active liver disease.
A previous history of pure red blood cell remittance
A 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 conditions that can cause anemia such as iron, folic acid or vitamin B12 deficiency
Trial design
Treatments tested in this trial
- AND017