Metastatic Pancreatic Cancer
Conditions
Brief summary
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
Interventions
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with metastatic pancreatic cancer 2. Patients have an ECOG performance status of 0 to 1 3. Patients with a life expectancy of at least 6 months
Exclusion criteria
1. Patients are unable to swallow oral medications 2. Patients with severe complication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities (DLT) | 28 days |
| Adverse event (AE) | Up to 28 days after the last dose |
Secondary
| Measure | Time frame |
|---|---|
| Anti-ONO-4538 antibody | Through study completion, an average of 6 months |
| Objective Response Rate (ORR) | Through study completion, an average of 6 months |
| Disease Control Rate (DCR) | Through study completion, an average of 6 months |
| Overall Survival (OS) | Through study completion, an average of 1 year |
| Progression-Free Survival (PFS) | Through study completion, an average of 6 months |
| Duration of Response (DOR) | Through study completion, an average of 6 months |
| Pharmacokinetics (Plasma concentration of ONO-7475) | Up to Cycle16 |
| Best Overall Response (BOR) | Through study completion, an average of 6 months |
| Percent change in the sum diameters of the target lesions | Through study completion, an average of 6 months |
| Maximum percent change in the sum diameters of the target lesions | Through study completion, an average of 6 months |
| CEA | Through study completion, an average of 6 months |
| CA19-9 | Through study completion, an average of 6 months |
| Time to Response (TTR) | Through study completion, an average of 6 months |
| Pharmacokinetics (Plasma concentration of ONO-4538) | Through study completion, an average of 6 months |
Countries
Japan
Outcome results
None listed