US 12,144,809 B1
Treatment of prostate cancer
Vijaykumar Reddy Rajasekhar, Apple Valley, CA (US); Brendan Mark Johnson, Chapel Hill, NC (US); David B. Maclean, Cambridge, MA (US); Lynn Seely, San Mateo, CA (US); Paul N. Mudd, Jr., Cary, NC (US); and Hélène M. Faessel, Cambridge, MA (US)
Assigned to Sumitomo Pharma Switzerland GmbH, Basel (CH); and Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed by Sumitomo Pharma Switzerland GmbH, Basel (CH); and Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed on Jun. 28, 2024, as Appl. No. 18/758,904.
Application 18/758,904 is a continuation of application No. 17/866,203, filed on Jul. 15, 2022.
Application 17/866,203 is a continuation of application No. 16/998,900, filed on Aug. 20, 2020, granted, now 11,583,526, issued on Feb. 21, 2023.
Application 16/998,900 is a continuation of application No. 16/563,161, filed on Sep. 6, 2019, granted, now 10,786,501, issued on Sep. 29, 2020.
Application 16/563,161 is a continuation of application No. 16/369,729, filed on Mar. 29, 2019, granted, now 10,449,191, issued on Oct. 22, 2019.
Application 16/369,729 is a continuation of application No. PCT/EP2017/074849, filed on Sep. 29, 2017.
Claims priority of provisional application 62/402,150, filed on Sep. 30, 2016.
Claims priority of provisional application 62/402,004, filed on Sep. 30, 2016.
Int. Cl. A61K 31/517 (2006.01); A61K 9/00 (2006.01); A61K 31/4164 (2006.01); A61K 31/4166 (2006.01); A61K 31/501 (2006.01); A61K 31/513 (2006.01); A61P 35/00 (2006.01)
CPC A61K 31/501 (2013.01) [A61K 9/0053 (2013.01); A61K 31/4166 (2013.01); A61K 31/513 (2013.01); A61P 35/00 (2018.01)] 29 Claims
 
1. A method of treating prostate cancer in a subject in need thereof, the method comprising:
(i) orally administering a loading dose of 360 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea to the subject;
(ii) beginning about one day after administration of the 360 mg loading dose, orally administering a single 120 mg solid preparation of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea to the subject once a day; and
(iii) co-administering a P-glycoprotein (P-gp) inhibitor to the subject at least six hours after the oral administration of the single 120 mg solid preparation of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea;
wherein the subject is in need of co-administration of the P-gp inhibitor.