Safety and efficacy of MIKE-1 in patients with advanced pancreatic cancer: a study protocol for an open-label phase I/II investigator-initiated clinical trial based on a drug repositioning approach that reprograms the tumour stroma

Table 2 Schedule of pharmacokinetic study (Start day of the AM80 dosing in the phase I study)

Day of measurement	Day of dosing (Day 1)						Day 2
Follow-up (hr)	0	1	2	4	8	10	24
Dosing of investigational drug	○
Blood sampling	○^a	○	○	○	○	○	○^a

Pharmacokinetic study on the start day of the AM80 dosing. The acceptable range of blood sampling time 1, 2, 4, 8, 10 and 24 h after dosing: the range will be about 15 min before and after the scheduled time after 1, 2, and 4 h and within 30 min before and after the scheduled time after 8 h
Pre-dosing blood will be sampled after breakfast and then the drug will be administered orally. Then, GEM/nab-PTX and premedication drugs will be administered in the methods usually performed in the institution. ^aBlood will be sampled before taking the drug

ISSN: 1471-2407