Cancer-Related Anemia
Conditions
Brief summary
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.
Interventions
DRUGAND017
Oral administration of AND017 capsules three times per week
Sponsors
Kind Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Non-myeloid malignancy diagnosed by cytology/histology. 2. ECOG score 0-2 and expected survival of 6 months or more. 3. 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. 4. Adequate hepatic and renal function. * Total bilirubin \< 1.5 x upper limit of normal (ULN). * Subjects with Gilbert's syndrome (unconjugated hyperbilirubinemia) have a total bilirubin \< 3 x ULN. * Aspartate aminotransferase (AST) * Alanine aminotransferase (ALT) \<2.5 x ULN * eGFR \>60 mL/min/1.73
Exclusion criteria
1. 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. 2. A medical history of significant liver disease or active liver disease. 3. A previous history of pure red blood cell remittance 4. 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 5. Active infection or inflammatory disease requiring systemic anti-infective therapy within 1 week prior to the first dose, including concurrent autoimmune diseases with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.) 6. Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.). 7. clinically significant bleeding (including the need for blood transfusion or a drop in hemoglobin ≥ 2 g/dL) within 4 weeks prior to the first dose, or a bleeding constitutional or bleeding risk that has not been medically or surgically corrected 8. uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values \> 90 mmHg and/or systolic blood pressure ≥ 160 mmHg at 16 weeks prior to and including screening testing) 9. concurrent congestive heart failure (New York Heart Association \[NYHA\] class III or higher) 10. clinically significant ECG abnormalities at screening assessment. 11. Have been treated with any hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) in the 8 weeks prior to randomization 12. have received treatment with an erythropoietic agent, androgenic anabolic steroid, testosterone enanthate or methandrostenolone within 6 weeks prior to screening assessment. 13. a history of significant medical or major surgical procedure within 3 months prior to the screening assessment or elective surgery planned during the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of responding patients | From Baseline to Week 6 or End of Treatment visit | Responding patient is defined as those with a maximum elevated hemoglobin level greater than 10% of baseline from baseline to five weeks after dosing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum change in hemoglobin from baseline to 5 weeks post-dose | From Baseline to Week 6 or End of Treatment visit | 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 | From Baseline to Week 6 or at 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 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 patients who achieve a greater than 10% increase in hemoglobin over baseline during treatment |
| Percentage of subjects requiring blood transfusions during the trial | From Baseline to Week 6 or at End of Treatment visit | Percentage of subjects requiring blood transfusions during the trial |
| Transfusion treatment rate | From Baseline to Week 6 or End of Treatment visit | The percentage of subjects who need to receive blood transfusion during the trial |
Contacts
CONTACTYusha Zhu, MD, PhD
STUDY_DIRECTORYusha Zhu, MD, PhD
Kind Pharmaceuticals LLC
Outcome results
None listed