Claims for Patent: 12,239,653

Summary for Patent: 12,239,653

Title:	Combination decitabine and cedazuridine solid oral dosage forms
Abstract:	Embodiments of the present invention provide solid oral dosage forms that upon daily administration to a subject provide plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily IV dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided according to embodiments of the present invention are solid oral dosage forms wherein upon daily administration to a subject provides a pharmacodynamic effect that is equivalent to the pharmacodynamic effect for a daily intravenous dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided are methods of treatment using a solid oral dosage form according to an embodiment of the invention.
Inventor(s):	Aram Oganesian, Nipun Davar, Jim Hwaicher Kou
Assignee:	Taiho Pharmaceutical Co Ltd , Astex Pharmaceuticals Inc
Application Number:	US17/904,536
Patent Claims:	1. A method of treating a disorder that is treatable with decitabine in a subject in need thereof, comprising administering to the subject a solid oral dosage form consisting of 100 mg cedazuridine, 35 mg decitabine, lactose monohydrate, hydroxypropyl methyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate, and optionally a coating, wherein the solid oral dosage form upon daily administration to a human provides plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily intravenous dose of decitabine of 20 mg/m2 administered as a 1 h infusion, thereby treating the disorder. 2. The method of claim 1, wherein the disorder that is treatable with decitabine is a hyperproliferative disorder. 3. The method of claim 2, wherein the disorder that is treatable with decitabine is cancer. 4. The method of claim 3, wherein the cancer is selected from hematological cancers and solid cancers. 5. The method of claim 4, wherein the hematological cancer is selected from myelodysplastic syndromes (MDS), leukemia, and lymphoma. 6. The method of claim 5, wherein the leukemia is acute lymphocytic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myeloproliferative neoplasms, or chronic myelomonocytic leukemia. 7. The method of claim 5, wherein the lymphoma is Hodgkin's Lymphoma, Non-Hodgkin lymphoma, or T-cell lymphoma. 8. The method of claim 5, wherein the myelodysplastic syndromes (MDS) is lower risk MDS. 9. The method of claim 8, wherein the lower risk MDS is a low International Prognostic Scoring System (IPSS) score and/or an intermediate 1 IPSS score. 10. The method of claim 4, wherein the solid cancer is selected from pancreatic cancer, ovarian cancer, peritoneal cancer, non-small cell lung cancer, breast cancer, neuroectodermal tumors, and sarcomas.