- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2021-07-30
2026-12-31
2026-12-31
32
NCT06532344
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
INTERVENTIONAL
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
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-07-29 | N/A | 2024-11-11 |
2024-07-29 | N/A | 2024-11-14 |
2024-08-01 | N/A | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: ONO-7913+ONO-4538+mFFX | DRUG: ONO-7913
DRUG: ONO-4538
DRUG: Oxaliplatin
DRUG: Levofolinate
DRUG: Irinotecan
DRUG: Fluorouracil
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities（DLT） | 28 days | |
| Adverse event(AE) | UP to 30 days after the last dose |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | |
| Progression-free survival (PFS) | Through study completion, an average of 6 months | |
| Duration of response (DOR) | Through study completion, an average of 6 months | |
| Time to response (TTR) | Through study completion, an average of 6 months | |
| Best overall response (BOR) | Through study completion, an average of 6 months | |
| Percentage of change in the sum of tumor diameters of target lesions | Through study completion, an average of 6 months | |
| Maximum percentage of change in the sum of tumor diameters of target lesions | Through study completion, an average of 6 months | |
| Changes in tumor markers (CEA and CA19-9) | Through study completion, an average of 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
