Trials / Active Not Recruiting
Active Not RecruitingNCT06547385
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-4578 | Specified dose on specified days |
| DRUG | ONO-4538 | Specified dose on specified days |
| DRUG | Capecitabine | Specified dose on specified days |
| DRUG | Oxaliplatin | Specified dose on specified days |
| DRUG | Fluorouracil | Specified dose on specified days |
| DRUG | Calcium Levofolinate Hydrateb | Specified dose on specified days |
| DRUG | Bevacizumab | Specified dose on specified days |
Timeline
- Start date
- 2021-01-13
- Primary completion
- 2027-10-31
- Completion
- 2027-10-31
- First posted
- 2024-08-09
- Last updated
- 2024-08-09
Locations
9 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT06547385. Inclusion in this directory is not an endorsement.