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Trial Title:
A Study of AND017 to Treat Cancer Related Anemia in Patients Not Receiving Chemotherapy
NCT ID:
NCT06075043
Condition:
Cancer-Related Anemia
Conditions: Official terms:
Anemia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AND017
Description:
Oral administration of AND017 capsules three times per week
Arm group label:
AND017 Dose A three times weekly
Arm group label:
AND017 Dose B three times weekly
Arm group label:
AND017 Dose C three times weekly
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 2024
Completion date:
August 2027
Lead sponsor:
Agency:
Kind Pharmaceuticals LLC
Agency class:
Industry
Source:
Kind Pharmaceuticals LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075043
