Trials / Completed
CompletedNCT06538207
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-4578 | Specified dose on specified days |
| DRUG | ONO-4538 | Specified dose on specified days |
| DRUG | Oxaliplatin | Specified dose on specified days |
| DRUG | Levofolinate | Specified dose on specified days |
| DRUG | Irinotecan | Specified dose on specified days |
| DRUG | Fluorouracil | Specified dose on specified days |
| DRUG | Gemcitabine | Specified dose on specified days |
| DRUG | Nab-Paclitaxel | Specified dose on specified days |
Timeline
- Start date
- 2021-01-13
- Primary completion
- 2024-10-01
- Completion
- 2025-01-30
- First posted
- 2024-08-05
- Last updated
- 2025-02-06
Locations
9 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT06538207. Inclusion in this directory is not an endorsement.