Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AND017 Dose A three times weekly | Experimental |
| |
| AND017 Dose B three times weekly | Experimental |
| |
| AND017 Dose C three times weekly | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AND017 | Drug | Oral administration of AND017 capsules three times per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to Week 6 or End of Treatment visit |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion treatment rate | The percentage of subjects who need to receive blood transfusion during the treatment | From baseline to Week 6 or End of Treatment visit |
| Mean and change from baseline in hemoglobin levels at each study visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusha Zhu, MD, PhD | Contact | 6467252552 | yushazhu@kindpharmaceutical.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Mean and change from baseline in hemoglobin levels at each study visit
| 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 | 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 | 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 | At baseline and Week 6 |
| Time for hemoglobin reaching an elevation of >10% from baseline during treatment | Time for hemoglobin reaching an elevation of >10% from baseline during treatment | From baseline to Week 6 or End of Treatment visit |