The purpose of this study is to determine the safety and efficacy of AND017 after 6 weeks of treatment in patients with cancer-related anemia who are 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 patient
Responding patient is defined as those with a maximum change from baseline in hemoglobin level greater than 10% during the treatment
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 treatment
Time frame: From baseline to Week 6 or End of Treatment visit
Mean and change from baseline in hemoglobin levels at each study visit
Mean and change from baseline in hemoglobin levels at each study visit
Time frame: From baseline to Week 6 or End of Treatment visit
The maximum change from baseline in hemoglobin during the treatment
The maximum change from baseline in hemoglobin during the treatment
Time frame: From baseline to Week 6 or End of Treatment visit
Percentage of visits in which subjects maintained a hemoglobin between elevation >10% of baseline and hemoglobin<12.0 g/dL after reaching an elevation of 10% from baseline
Percentage of visits in which subjects maintained a hemoglobin between elevation \>10% of baseline and hemoglobin\<12.0 g/dL after reaching an elevation of 10% from baseline
Time frame: From baseline to Week 6 or End of Treatment visit
Percentage of subjects whose hemoglobin remained between elevation >10% of baseline and hemoglobin< 12.0 g/dL after 5 weeks treatment
Percentage of subjects whose hemoglobin remained between elevation \>10% of baseline and hemoglobin\< 12.0 g/dL after 5 weeks treatment
Time frame: At baseline and Week 6
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Time for hemoglobin reaching an elevation of >10% from baseline during treatment
Time for hemoglobin reaching an elevation of \>10% from baseline during treatment
Time frame: From baseline to Week 6 or End of Treatment visit