NCT06547385Active, not recruitingPhase 1
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
ONO-4578 Phase I Study An Open-label, Uncontrolled Study of First-line Combination Therapy of ONO-4578 and ONO-4538 With Standard Therapy XELOX Plus Bevacizumab or FOLFOX Plus Bevacizumab in Patients With Unresectable, Advanced or Recurrent Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
To evaluate the tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent colorectal cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 1 Aug 2024
- Start date
- 13 Jan 2021
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT06547385
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 40
- From 13 Jan 2021 to the primary completion date, 31 Oct 2027
- 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.
Prior treatment
- Patients are unable to swallow oral medications
Other
- Patients with severe complication
Who the study is looking for
- Unresectable colorectal cancer
- Life expectancy of at least 3 months
- 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 |
|---|---|---|---|
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Hidaka-shi | Japan | Unknown status |
| Saitama Cancer Center Coordinator of this site? Confirm its status | Ina | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Kobe City Hospital Organization Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Koto-Ku | Japan | Unknown status |
| NHO Osaka National Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka General Medical Center Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki-shi | 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.