To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan
Dose-limiting toxicities(DLT)
Time frame: 28 days
Adverse event(AE)
Time frame: UP to 30 days after the last dose
Pharmacokinetics(serum concentration of ONO-7913)
Time frame: Through study completion, an average of 6 months
Pharmacokinetics(serum concentration of ONO-4538)
Time frame: Through study completion, an average of 6 months
Overall response rate (ORR)
Time frame: Through study completion, an average of 6 months
Disease control rate (DCR)
Time frame: Through study completion, an average of 6 months
Overall survival (OS)
Time frame: Through study completion, an average of 6 months
Progression-free survival (PFS)
Time frame: Through study completion, an average of 6 months
Duration of response (DOR)
Time frame: Through study completion, an average of 6 months
Time to response (TTR)
Time frame: Through study completion, an average of 6 months
Best overall response (BOR)
Time frame: Through study completion, an average of 6 months
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
The Cancer Institute Hospital ofJFCR
Koto-ku, Tokyo, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
National Cancer Center Hospital
Chūōku, Japan
Percentage of change in the sum of tumor diameters of target lesions
Time frame: Through study completion, an average of 6 months
Maximum percentage of change in the sum of tumor diameters of target lesions
Time frame: Through study completion, an average of 6 months
Changes in tumor markers (CEA and CA19-9)
Time frame: Through study completion, an average of 6 months