US 12,357,632 B2
Methods of treating cholangiocarcinoma
Riccardo Panicucci, Bluffton, SC (US); Michael Monteith, Raleigh, NC (US); Gang Li, San Diego, CA (US); Susan Arangio, Los Altos, CA (US); Craig Berman, Mill Valley, CA (US); Michael Howland, San Francisco, CA (US); Daniel Mulreany, San Francisco, CA (US); and Carl Dambkowski, San Mateo, CA (US)
Assigned to QED Therapeutics, Inc., Palo Alto, CA (US)
Appl. No. 17/613,651
Filed by QED Therapeutics, Inc., Palo Alto, CA (US)
PCT Filed May 28, 2020, PCT No. PCT/US2020/034881
§ 371(c)(1), (2) Date Nov. 23, 2021,
PCT Pub. No. WO2020/243273, PCT Pub. Date Dec. 3, 2020.
Claims priority of provisional application 62/853,431, filed on May 28, 2019.
Prior Publication US 2022/0233536 A1, Jul. 28, 2022
Int. Cl. A61K 31/50 (2006.01); A61K 31/506 (2006.01); A61P 35/04 (2006.01)
CPC A61K 31/506 (2013.01) [A61P 35/04 (2018.01)] 17 Claims
 
1. A method for treating advanced or metastatic cholangiocarcinoma in a subject in need thereof, comprising:
administering infigratinib monophosphate salt once daily in an amount of about 50, 75, 100, or 125 milligrams (mg) by weight in its free base form,
wherein the subject has progression of the cholangiocarcinoma after previous administration of another therapy; the cholangiocarcinoma has an FGFR2 gene fusion, translocation, or another genetic alteration; the about 125 mg amount of infigratinib monophosphate salt is provided as a 100 mg unit dose and a 25 mg unit dose, each by weight in its free base form; the infigratinib monophosphate salt is administered at least 1 hour before the subject consumes food or at least 2 hours after the subject has consumed food; and administering the infigratinib monophosphate salt comprises a 28-day cycle in which the infigratinib monophosphate salt is administered to the subject for 3 consecutive weeks, and no infigratinib monophosphate salt is administered for 1 week.