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 various doses of AND017 after 6 weeks of treatment in subjects with anemia of cancer who are not 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 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. | 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 trial | From Baseline to Week 6 or End of Treatment visit |
| Maximum change in hemoglobin from baseline to 5 weeks post-dose |
Not provided
Main Inclusion Criteria:
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.
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 |
| Name | Affiliation | Role |
|---|---|---|
| Yusha Zhu, MD, PhD | Kind Pharmaceuticals LLC | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Maximum change in hemoglobin from baseline to 5 weeks post-dose
| 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 | 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 | 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 | From Baseline to Week 6 or at End of Treatment visit |