COMPOSITIONS AND TREATMENTS WITH NIROGACESTAT
The present disclosure relates to compositions and methods of treatment comprising nirogacestat or a pharmaceutically acceptable salt thereof.
1 - 31 . (canceled)
32 . A method for treating multiple myeloma comprising administration to a patient in need thereof 200 mg per day of nirogacestat or a pharmaceutically acceptable salt thereof to a patient in need thereof.
33 . A method for treating multiple myeloma comprising administration to a patient in need thereof 100 mg per day of nirogacestat or a pharmaceutically acceptable salt thereof to a patient in need thereof.
34 . The method of claim 32 , wherein the pharmaceutically acceptable salt form is a hydrobromide salt form.
35 . The method of claim 34 , wherein the hydrobromide salt form is a dihydrobromide salt form.
36 . The method of claim 32 , wherein the patient is a human.
37 . The method of claim 32 , wherein the nirogacestat or a pharmaceutically acceptable salt thereof is administered orally.
38 . The method of claim 37 , wherein the nirogacestat or a pharmaceutically acceptable salt thereof is administered orally as a solid dosage form.
39 . The method of claim 38 , wherein the solid dosage form is a tablet or capsule.
40 . The method of claim 32 , wherein the nirogacestat or pharmaceutically acceptable salt thereof is administered once daily.
41 . The method of claim 32 , wherein the nirogacestat or pharmaceutically acceptable salt thereof is administered two, three, or four times per day.
42 . (canceled)
43 . A method for treating multiple myeloma comprising once daily administration of 150 mg nirogacestat or a pharmaceutically acceptable salt thereof to a patient in need thereof.
44 - 52 . (canceled)
53 . The method of claim 33 , wherein the method comprises administering to the patient a 100 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 225 ng/ml.
54 . (canceled)
55 . The method of claim 33 , wherein the method comprises administering to the patient a 100 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 3000 ng h/ml.
56 - 62 . (canceled)
63 . A method for treating multiple myeloma in a patient in need thereof comprising administering to the patient an 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.
64 . The method of claim 63 , wherein the method comprises administering to the patient an 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 225 ng/ml.
65 . The method of claim 63 , wherein the oral dosage provides an in vivo area under the plasma curve (AUC inf ) of less than 700 ng h/ml.
66 . The method of claim 63 , wherein the oral dosage provides an in vivo area under the plasma curve (AUC inf ) of less than 3000 ng h/ml.
67 - 80 . (canceled)