This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Dose-limiting toxicities (DLT)
Time frame: 28 days
Adverse event (AE)
Time frame: Up to 28 days after the last dose
Pharmacokinetics (Plasma concentration of ONO-7475)
Time frame: Up to Cycle16
Pharmacokinetics (Plasma concentration of ONO-4538)
Time frame: Through study completion, an average of 6 months
Anti-ONO-4538 antibody
Time frame: Through study completion, an average of 6 months
Objective 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 1 year
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Specified dose on specified days
Osaka International Cancer Institute
Osaka, Osaka, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Hpspital
Bunkyo-ku, Tokyo, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, Japan
Best Overall Response (BOR)
Time frame: Through study completion, an average of 6 months
Percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 6 months
Maximum percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 6 months
CEA
Time frame: Through study completion, an average of 6 months
CA19-9
Time frame: Through study completion, an average of 6 months