NCT06538207CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 29 Jul 2024
- Start date
- 13 Jan 2021
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Pancreatic cancer
- NCT number
- NCT06538207
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 46
- From 13 Jan 2021 to the primary completion date, 1 Oct 2024
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 2\. Patients with multiple primary cancers
Other
- 1\. Patients with severe complication
Who the study is looking for
- 1\. Pancreatic invasive ducatal adenocarcinoma
- 2\. Life expectancy of at least 3 months
- 3\. Patients with ECOG performance status 0 or 1
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō-Ku | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| Seirei Hamamatsu General Hospital Coordinator of this site? Confirm its status | Hamamatsu | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Koto-ku | Japan | Unknown status |
| Kyorin University Hospital Coordinator of this site? Confirm its status | Mitaka-shi | Japan | Unknown status |
| Keio University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.