An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer
1 other identifier
interventional
32
1 country
9
Brief Summary
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.
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 Jul 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
July 30, 2021
CompletedFirst Submitted
Initial submission to the registry
July 29, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 14, 2024
November 1, 2024
5.4 years
July 29, 2024
November 11, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicities（DLT）
28 days
Adverse event(AE)
UP to 30 days after the last dose
Secondary Outcomes (12)
Pharmacokinetics（serum concentration of ONO-7913）
Through study completion, an average of 6 months
Pharmacokinetics（serum concentration of ONO-4538）
Through study completion, an average of 6 months
Overall 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 6 months
- +7 more secondary outcomes
Study Arms (1)
ONO-7913+ONO-4538+mFFX
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- \. Untreated metastatic pancreatic cancer
- \. 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
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
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
- NA
- 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 1, 2024
Study Start
July 30, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 14, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share