METHODS OF TREATING DESMOID TUMORS WITH (S)-2-(((S)-6,8-DIFLUORO-1,2,3,4-TETRAHYDRONAPHTHALEN-2-YL)AMINO)-N-(1-(2-METHYL-1-(NEOPENTYLAMINO)PROPAN-2-YL)-1H-IMIDAZOL-4-YL)PENTANAMIDE
The present disclosure relates to: a) solid state forms of hydrobromide salts of Compound 1; b) pharmaceutical compositions comprising one or more solid state forms of hydrobromide salts of Compound 1, and, optionally, a pharmaceutically acceptable carrier; c) methods of treating tumors or cancers by administering one or more solid state forms of hydrobromide salts of Compound 1 to a subject in need thereof; and d) methods for the preparation of solid state forms of Compound 1.
1 - 144 . (canceled)
145 . A method for treating desmoid tumor comprising administration to a patient in need thereof an oral dosage form comprising 50 mg of nirogacestat or a pharmaceutically acceptable salt thereof to a patient in need thereof.
146 . The method of claim 145 , wherein the nirogacestat or pharmaceutically acceptable salt thereof is administered once daily.
147 . The method of claim 145 , wherein the nirogacestat or pharmaceutically acceptable salt thereof is administered twice daily.
148 . The method of claim 145 , wherein the pharmaceutically acceptable salt form is a hydrobromide salt form.
149 . The method of claim 145 , wherein the progression free survival of the patient is improved.
150 . The method of claim 145 , wherein the patient response rate is more than 50%.
151 . The method of claim 145 , wherein the risk of disease progression in the patient is reduced more than 50%.
152 . A method for treating desmoid tumor in a patient in need thereof comprising administering to the patient a 50 mg oral dosage of nirogacestat or a pharmaceutically acceptable salt thereof wherein the oral dosage provides a mean maximum drug plasma concentration (C max ) of more than 100 ng/ml.
153 . The method of claim 152 , wherein the nirogacestat or pharmaceutically acceptable salt thereof is administered once daily.
154 . The method of claim 152 , wherein the nirogacestat or pharmaceutically acceptable salt thereof is administered twice daily.
155 . The method of claim 152 , wherein the pharmaceutically acceptable salt form is a hydrobromide salt form.
156 . The method of claim 152 , wherein the progression free survival of the patient is improved.
157 . The method of claim 152 , wherein the patient response rate is more than 50%.
158 . The method of claim 152 , wherein the risk of disease progression in the patient is reduced more than 50%.
159 . A method for treating desmoid tumor in a patient in need thereof comprising administering to the patient a 50 mg oral dosage of nirogacestat or a pharmaceutically acceptable salt thereof wherein the oral dosage provides an in vivo area under the plasma curve (AUC inf ) of less than 700 ng h/ml.
160 . The method of claim 159 , wherein the nirogacestat or pharmaceutically acceptable salt thereof is administered once daily.
161 . The method of claim 159 , wherein the nirogacestat or pharmaceutically acceptable salt thereof is administered twice daily.
162 . The method of claim 159 , wherein the pharmaceutically acceptable salt form is a hydrobromide salt form.
163 . The method of claim 159 , wherein the progression free survival of the patient is improved.
164 . The method of claim 159 , wherein the patient response rate is more than 50%.
165 . The method of claim 159 , wherein the risk of disease progression in the patient is reduced more than 50%.