A Study of AND017 to Treat Cancer Related Anemia in Patients Not Receiving Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Open-label Study of AND017 for the Treatment of Anemia of Cancer in Patients Not Receiving Chemotherapy

Conditions
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Cancer-Related Anemia

Intervention / Treatment
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* Drug: AND017


Participation Criteria
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Eligibility Criteria
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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. 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: 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. A medical history of significant liver disease or active liver disease. A previous history of pure red blood cell remittance 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 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.) Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.). 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 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) concurrent congestive heart failure (New York Heart Association [NYHA] class III or higher) clinically significant ECG abnormalities at screening assessment. Have been treated with any hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) in the 8 weeks prior to randomization have received treatment with an erythropoietic agent, androgenic anabolic steroid, testosterone enanthate or methandrostenolone within 6 weeks prior to screening assessment. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AND017 Dose A three times weekly<br> | Drug: AND017<br>* Oral administration of AND017 capsules three times per week<br>|
| Experimental: AND017 Dose B three times weekly<br> | Drug: AND017<br>* Oral administration of AND017 capsules three times per week<br>|
| Experimental: AND017 Dose C three times weekly<br> | Drug: AND017<br>* Oral administration of AND017 capsules three times per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |