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.
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.
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
Sequential
AND017
DrugOral administration of AND017 capsules three times per week
Percentage of responding patients
Responding patient is defined as those with a maximum elevated hemoglobin level greater than 10% of baseline from baseline to five weeks after dosing.
Transfusion treatment rate
The percentage of subjects who need to receive blood transfusion during the trial
Maximum change in hemoglobin from baseline to 5 weeks post-dose
Maximum change in hemoglobin from baseline to 5 weeks post-dose
Percentage of visits in which subjects maintained a hemoglobin elevation between >10% and 12.0 g/dL above baseline after reaching 10% of baseline
Percentage of visits in which subjects maintained a hemoglobin elevation between \>10% and 12.0 g/dL above baseline after reaching 10% of baseline
Percentage of patients who achieve a greater than 10% increase in hemoglobin over baseline during treatment
Percentage of patients who achieve a greater than 10% increase in hemoglobin over baseline during treatment
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
