Pharmaceutical composition containing a hypomethylating agent and a histone deacetylase inhibitor
A pharmaceutical composition for induction therapy which has a hypomethylating agent and a histone deacetylase inhibitor (“HDAC inhibitor”); wherein the hypomethylating agent is a DNA and histone methylation inhibitor such as cladribine and the HDAC inhibitor is, for example, entinostat, panobinostat, vorinostat, and/or romedepsin; further wherein the hypomethylating agent and the HDAC inhibitor are combined in formulations for various administrations including e.g., a continuous delivery system such as a transdermal patch of at least one reservoir or a plurality of reservoirs, oral, a fixed-dose oral combination, intravenous, and combinations thereof. This pharmaceutical composition for induction therapy is used with a monoclonal antibody in the treatment of various cancers, sarcomas, and other malignancies.
1. A transdermal composition for induction therapy used with a monoclonal antibody treatment, the composition comprising therapeutically effective amounts of cladribine; and entinostat.
2. The composition of claim 1 , wherein the composition is prepared for administration to a patient via a transdermal patch.
3. The composition of claim 1 , wherein the cladribine comprises about 20-100 mg/m 2 .
4. The composition of claim 1 , wherein the entinostat comprises about 40-80 mg/m 2 .
5. The composition of claim 1 , where in the cladribine comprises about 5-15 mg/m 2 .
6. The composition of claim 1 , wherein the entinostat comprises about 10-20 mg/m 2 .
7. A method of induction therapy used with a monoclonal antibody in a treatment in a patient in need thereof comprising transdermally administering to the patient a therapeutically effective amount of cladribine and entinostat.
8. The method of claim 7 , wherein the cladribine and the entinostat are administered via a transdermal patch.
9. The method of claim 8 , wherein the cladribine is administered in an amount of about 5-20 mg/m 2 .
10. The method of claim 8 , wherein the entinostat is administered in an amount of about 10-80 mg/m 2 .
11. The method of claim 8 , wherein the cladribine is administered in an amount of about 5-100 mg/m 2 and the entinostat is administered in an amount of about 10-80 mg/m 2 .