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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Oral 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.
Time frame: From Baseline to Week 6 or End of Treatment visit
Transfusion treatment rate
The percentage of subjects who need to receive blood transfusion during the trial
Time frame: From Baseline to Week 6 or End of Treatment visit
Maximum change in hemoglobin from baseline to 5 weeks post-dose
Maximum change in hemoglobin from baseline to 5 weeks post-dose
Time frame: From Baseline to Week 6 or End of Treatment visit
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
Time frame: From Baseline to Week 6 or at End of Treatment visit
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
Time frame: From Baseline to Week 6 or at End of Treatment visit
Percentage of subjects requiring blood transfusions during the trial
Percentage of subjects requiring blood transfusions during the trial
Time frame: From Baseline to Week 6 or at End of Treatment visit
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