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2023-12-06
2027-09-30
2028-03-31
87
NCT06532331
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
INTERVENTIONAL
A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer
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
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 |
|---|---|---|
2024-07-28 | N/A | 2025-04-15 |
2024-07-29 | N/A | 2025-04-18 |
2024-08-01 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: ONO-7475+GnP | DRUG: ONO-7475
DRUG: Nab-paclitaxel
DRUG: Gemcitabine
|
| EXPERIMENTAL: ONO-7475＋ONO-4538＋GnP | DRUG: ONO-7475
DRUG: ONO-4538
DRUG: Nab-paclitaxel
DRUG: Gemcitabine
|
| 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 of ONO-7475) | Up to Cycle16 | |
| Pharmacokinetics (Plasma concentration of ONO-4538) | Through study completion, an average of 6 months | |
| 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 | |
| Time to Response (TTR) | Through study completion, an average of 6 months | |
| 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 |
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:
18 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.
