To hear about similar clinical trials, please enter your email below

Trial Title: A Study of Efficacy and Safety of AND017 in Patients with Myelodysplastic Syndrome

NCT ID: NCT06304103

Condition: Myelodysplastic Syndromes

Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome

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: Administer AND017 once per day (QD)
Arm group label: AND017 capsules 12 mg
Arm group label: AND017 capsules 30 mg
Arm group label: AND017 capsules 4 mg

Summary: This is a Phase 2, multicenter, randomized, open-lable, dose ranging study to evaluate the efficacy and safety of AND017 for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS) in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB).

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Diagnosed of primary myelodysplastic syndrome with a PISS-R grading of very low, low or intermediate risk and a bone marrow primitive cell count < 5%, the time frame for this grading assessment should be at least 12 weeks prior to the first dose 2. Non-5q(del)-associated myelodysplastic syndrome. 3. Two non-transfused hemoglobin ≥ 6.0 g/dL and < 10.0 g/dL, averaged over the screening period, at least one week and more apart, and with no more than 1.3 g/dL difference between the two Hb. 4. Non-transfused subjects (NTD cohort) defined as no red blood cell transfusion in the 16 weeks prior to randomization or low transfusion load subjects defined as 3-7 pRBC units transfused in the 16 weeks prior to randomization and at least two different time points (LTB-1 cohort) or 1-2 pRBC units transfused at one time point in the 16 weeks prior to randomization ( LTB-2 cohort) (except in the case of transfusion for treatment of other comorbidities such as blood loss, surgery, etc.); 5. Baseline EPO level ≤ 500 mU/mL 6. Platelets ≥ 30,000 /mm3 and absolute neutrophil count ≥ 800/mm3 7. Adequate liver function with: - Total bilirubin <2 x upper limit of normal (ULN) (subjects with Gilbert's syndrome, i.e., unconjugated hyperbilirubinemia, have a total bilirubin <3 x ULN) - Aspartate aminotransferase (AST) <3 x ULN - Alanine aminotransferase (ALT) <3×ULN Exclusion Criteria: 1. Diagnosed of secondary myelodysplastic syndrome or concurrent anemia from a cause other than the primary myelodysplastic syndrome. 2. Significant myelofibrosis (fibrosis ≥ 2+). 3. Planned clearing chemotherapy or whole brain spinal cord radiotherapy during the study period. 4. Previous diagnosis of MDS IPSS-R high or very high risk. 5. Prior or planned hematopoietic stem cell transplant during the study period. 6. Received granulocyte colony-stimulating factor (G-CSF), or thrombopoietin, or thrombopoietin receptor agonist therapy within 8 weeks prior to the first dose; 7. Treatment with antithymocyte globulin, azacitidine, decitabine, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to the first dose. 8. The presence of active infection or inflammatory disease requiring systemic anti-infective therapy, including concomitant autoimmune disease with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.) 9. Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.) 10. Inability to take oral medications, or a history of gastrectomy, concomitant gastroparesis, or other conditions that may have an impact on the absorption of gastrointestinal medications (excluding gastric polyps or colonic polypectomy) 11. Clinically significant bleeding (including transfusions required to treat bleeding or bleeding resulting in a decrease 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. 12. Uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg at 16 weeks prior to and including screening testing) 13. Comorbid heart failure (New York Heart Association [NYHA] class III or higher) 14. Medical history of significant liver disease or active liver disease at screening assessment 15. Have been treated with any other hypoxia-inducing factor-prolyl hydroxylase inhibitor (HIF-PHI) in the 8 weeks prior to the first dose 16. Have been treated with an erythropoietic ESA within 8 weeks prior to the first dose 17. Have been treated with an androgenic anabolic steroid, testosterone enanthate or methandrostenolone within 8 weeks prior to the first dose 18. Have been treated with an iron chelator within 8 weeks prior to the first dose

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: December 2024

Completion date: May 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/NCT06304103

Login to your account

Did you forget your password?