COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Provided herein are compositions and methods for treating myelofibrosis in a subject. The methods comprise administering to the subject an effective amount of compound which is which is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide or a pharmaceutical salt thereof or a hydrate thereof.
1 - 69 . (canceled)
70 . A pharmaceutical formulation comprising a compound that is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide or a pharmaceutically acceptable salt and/or hydrate thereof, characterized in that the formulation provides:
a steady state patient C max of the compound that is achieved within 2 to 4 hours post administration; and/or
a steady state patient C max of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration.
71 . The formulation of claim 70 , characterized in that the formulation provides a C max of the compound that is achieved within 2 to 4 hours post administration.
72 . The formulation of claim 70 , characterized in that the formulation provides a C max of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration.
73 . The formulation of claim 70 , wherein the formulation further comprises a filler.
74 . The formulation of claim 73 , wherein the filler is a microcrystalline cellulose.
75 . The formulation of claim 70 , wherein the formulation further comprises a lubricant.
76 . The formulation of claim 73 , wherein the formulation further comprises a lubricant.
77 . The formulation of claim 74 , wherein the formulation further comprises a lubricant.
78 . The formulation of claim 75 , wherein the lubricant is sodium stearyl fumarate.
79 . The formulation of claim 76 , wherein the lubricant is sodium stearyl fumarate.
80 . The formulation of claim 77 , wherein the lubricant is sodium stearyl fumarate.
81 . The formulation of claim 70 , wherein the formulation comprises about 400 mg of the compound.
82 . The formulation of claim 73 , wherein the formulation comprises about 400 mg of the compound.
83 . The formulation of claim 74 wherein the formulation comprises about 400 mg of the compound.
84 . The formulation of claim 75 , wherein the formulation comprises about 400 mg of the compound.
85 . The formulation of claim 76 , wherein the formulation comprises about 400 mg of the compound.
86 . The formulation of claim 77 , wherein the formulation comprises about 400 mg of the compound.
87 . The formulation of claim 78 , wherein the formulation comprises about 400 mg of the compound.
88 . The formulation of claim 79 , wherein the formulation comprises about 400 mg of the compound.
89 . The formulation of claim 80 , wherein the formulation comprises about 400 mg of the compound.
90 . The formulation of claim 70 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate.
91 . The formulation of claim 73 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate.
93 . The formulation of claim 74 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate.
94 . The formulation of claim 75 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate.
95 . The formulation of claim 76 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate.
96 . The formulation of claim 77 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate.
97 . The formulation of claim 78 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate.
98 . The formulation of claim 79 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonami de dihydrochloride monohydrate.
99 . The formulation of claim 80 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate.