Granted Patent B2

US 12,589,094 · App. 18/590,002 · Granted Mar 31, 2026

Inventors: Hazel Hunt (Storrington, GB); Joseph Custodio (Menlo Park, CA)

Assignee: Corcept Therapeutics Incorporated

A61K31/4725A61K31/337A61P35/00

Abstract

Claims (13)

1 . A method of treating cancer according to a 28-day cycle of intermittent paclitaxel and relacorilant administration, wherein said 28-day cycle begins on day0, wherein said cancer comprises a solid tumor, comprising the following administrations to a patient in need of treatment for said cancer: a) administering an effective oral dose of relacorilant of between about 75 milligrams (mg) to about 200 mg on day 0, day 7, and day 14 of said 28-day cycle of intermittent paclitaxel and relacorilant administration; and then, b) administering, on day 1, day 8, and day 15 of said 28-day cycle of intermittent paclitaxel and relacorilant administration, an effective oral dose of relacorilant of between about 75 mg to about 200 mg and an effective dose of paclitaxel that is reduced by about 20% to about 35% from the paclitaxel single agent dose of about 100 mg/m 2 to about 125 mg/m 2 , wherein said single agent dose is the paclitaxel dose to be administered when paclitaxel is administered without other pharmaceutical agents; and then, c) administering, on day 2, day 9 and day 16 of said 28-day cycle of intermittent paclitaxel and relacorilant administration an effective oral dose of relacorilant of between about 75 mg to about 200 mg, wherein steps a), and b), and c) are intermittent administration steps in which paclitaxel administration is performed on days 1, 8, and 15 of said 28-day cycle, and in which relacorilant administration is performed on the day before, the day of, and the day after said paclitaxel administration, effective to provide the patient with an effective level of relacorilant and an effective level of paclitaxel at the same time, whereby the cancer comprising a solid tumor is treated according to a 28-day cycle of intermittent paclitaxel and relacorilant administration.

2 . The method of claim 1 , wherein said effective dose of paclitaxel is reduced from said single agent dose of paclitaxel by an amount selected from about 20%, about 25%, about 30%, and about 35%, when co-administered with relacorilant.

3 . The method of claim 1 , wherein said effective dose of paclitaxel is reduced from said single agent dose of paclitaxel to an effective dose of paclitaxel selected from about 72 mg/m 2 , about 75 mg/m 2 , about 80 mg/m 2 , about 83 mg/m 2 , about 88 mg/m 2 , about 94 mg/m 2 , and about 96 mg/m 2 of paclitaxel.

4 . The method of claim 1 , wherein paclitaxel is in the form of nab-paclitaxel.

5 . The method of claim 1 , wherein said effective oral dose of relacorilant is selected from 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, and 200 mg of relacorilant.

6 . The method of claim 1 , wherein said cancer is selected from ovarian cancer, pancreatic cancer, prostate cancer, esophageal cancer, and melanoma.

7 . The method of claim 1 , wherein paclitaxel is in the form of nab-paclitaxel, and wherein the dose of nab-paclitaxel is selected from about 60 mg/m 2 , about 72 mg/m 2 , about 75 mg/m 2 , about 80 mg/m 2 , and about 83 mg/m 2 of nab-paclitaxel administered by intravenous infusion on days 1, 8 and 15 of said 28-day cycle.

8 . A method of treating cancer according to a 28-day cycle of intermittent paclitaxel and relacorilant administration, wherein said 28-day cycle begins on day0, wherein said cancer comprises a solid tumor, comprising the following administrations to a patient in need of treatment for said cancer: a) administering an effective oral dose of relacorilant of between about 75 milligrams (mg) to about 200 mg on day 0, day 7, and day 14 of said 28-day cycle of intermittent paclitaxel and relacorilant administration; and then, b) administering an effective oral dose of relacorilant of between 75 mg to about 200 mg and an effective dose of paclitaxel of between about 60 mg/m 2 to about 95 mg/m 2 , on day 1, day 8, and day 15 of said 28-day cycle of intermittent paclitaxel and relacorilant administration, and then c) administering an effective oral dose of relacorilant of between about 75 mg to about 200 mg on day 2, day 9 and day 16 of said 28-day cycle of intermittent paclitaxel and relacorilant administration, wherein steps a), and b), and c) are intermittent administration steps in which paclitaxel administration is performed on days 1, 8, and 15 of said 28-day cycle, and in which relacorilant administration is performed on the day before, the day of, and the day after said paclitaxel administration, at times effective to provide the patient with an effective level of relacorilant and an effective level of paclitaxel at the same time, whereby the cancer comprising a solid tumor is treated according to a 28-day cycle of intermittent paclitaxel and relacorilant administration.

9 . The method of claim 8 , wherein said paclitaxel is in the form of nab-paclitaxel.

10 . The method of claim 8 , wherein said effective dose of paclitaxel is selected from about 60 mg/m 2 , about 65 mg/m 2 , about 70 mg/m 2 , about 75 mg/m 2 , about 80 mg/m 2 , about 85 mg/m 2 , about 90 mg/m 2 , and about 95 mg/m 2 of paclitaxel.

11 . The method of claim 8 , wherein said effective oral dose of relacorilant is selected from 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, and 200 mg of relacorilant.

12 . The method of claim 8 , wherein said cancer is selected from ovarian cancer, pancreatic cancer, prostate cancer, esophageal cancer, and melanoma.

13 . The method of claim 8 , wherein paclitaxel is in the form of nab-paclitaxel, wherein the dose of nab-paclitaxel is selected from about 60 mg/m 2 , about 72 mg/m 2 , about 75 mg/m 2 , about 80 mg/m 2 , and about 83 mg/m 2 of nab-paclitaxel administered by intravenous infusion on days 1, 8 and 15 of said 28-day cycle.

Assignments (1)

Continuity (4)

References Cited (400)