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2021-01-13
2024-10-01
2025-01-30
46
NCT06538207
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
INTERVENTIONAL
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
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.
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 | 2025-02-04 |
2024-08-01 | N/A | 2025-02-06 |
2024-08-05 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: ONO-4578+ONO-4538+mFFX | DRUG: ONO-4578
DRUG: ONO-4538
DRUG: Oxaliplatin
DRUG: Levofolinate
DRUG: Irinotecan
DRUG: Fluorouracil
|
| EXPERIMENTAL: ONO-4578+ONO-4538+GnP | DRUG: ONO-4578
DRUG: ONO-4538
DRUG: Gemcitabine
DRUG: Nab-Paclitaxel
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities（DLT） | 28 days | |
| Adverse event(AE) | UP to 28 days after the last dose |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | |
| Progression-free survival (PFS) | Up to 2 years | |
| Duration of response (DOR) | Up to 2 years | |
| Time to response (TTR) | Up to 2 years | |
| Best overall response (BOR) | Up to 2 years | |
| Percentage of change in the sum of tumor diameters of target lesions | Up to 2 years | |
| Maximum percentage of change in the sum of tumor diameters of target lesions | Up to 2 years | |
| Changes in tumor markers (CEA and CA19-9) | Up to 2 years |
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
