30
Participants
Start Date
March 30, 2022
Primary Completion Date
March 31, 2026
Study Completion Date
June 30, 2026
JPI-547
"* Subjects are administered this investigational product once a week for 5 days, and have wash-out period for 2 days (5 Days on-2 Days off).~* The investigational product is administered orally in a fasting state for 2 hours before and after meals at the same time (e.g., a certain time in the morning).~* Capsules should be swallowed whole and should not be chewed, crushed or split."
modified FOLFIRINOX
"* After IV administration of Oxaliplatin 65 mg/m2 for 2 hours~* After IV administration of Leucovorin 400 mg/m2 for 2 hours + IV administration of Irinotecan 135 mg/m2 for 90 minutes (Irinotecan is started 30 minutes after the start of Leucovorin administration and administered simultaneously during the last 90 minutes of Leucovorin administration, but administered separately using a Y-connector without mixing)~* Continuous IV infusion of 5-FU 2400 mg/m2 for 46 hours~* Repeated administration every 2 weeks on a 14-day cycle"
Gemcitabine-nab-paclitaxel
"* After IV administration of nab-paclitaxel 125 mg/m2 for 30 minutes~* IV administration of Gemcitabine 1000 mg/m2 for 30 minutes~* Administration on Days 1, 8, and 15 on a 28-day cycle"
RECRUITING
Seoul National University Bundang Hospital, Gyeonggi-do
RECRUITING
Samsung Medical Center, Seoul
RECRUITING
Seoul national university hospital, Seoul
RECRUITING
Severance Hospital, Seoul
Lead Sponsor
Onconic Therapeutics Inc.
INDUSTRY