An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer
2 other identifiers
interventional
46
1 country
9
Brief Summary
This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2021
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2021
CompletedFirst Submitted
Initial submission to the registry
July 29, 2024
CompletedFirst Posted
Study publicly available on registry
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedFebruary 6, 2025
February 1, 2025
3.7 years
July 29, 2024
February 4, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicities（DLT）
28 days
Adverse event(AE)
UP to 28 days after the last dose
Secondary Outcomes (12)
Pharmacokinetics (Plasma concentration for ONO-4578)
Up to 28 days after the last dose
Pharmacokinetics (Serum concentration for ONO-4538)
Up to 28 days after the last dose
Overall response rate (ORR)
Up to 2 years
Disease control rate (DCR)
Up to 2 years
Overall survival (OS)
Up to 2 years
- +7 more secondary outcomes
Study Arms (2)
ONO-4578+ONO-4538+mFFX
EXPERIMENTALONO-4578+ONO-4538+GnP
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- \. Pancreatic invasive ducatal adenocarcinoma
- \. Life expectancy of at least 3 months
- \. Patients with ECOG performance status 0 or 1
You may not qualify if:
- \. Patients with severe complication
- \. Patients with multiple primary cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2024
First Posted
August 5, 2024
Study Start
January 13, 2021
Primary Completion
October 1, 2024
Study Completion
January 30, 2025
Last Updated
February 6, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share