Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT06547385
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Unresectable colorectal cancer
- Life expectancy of at least 3 months
- Patients with ECOG performance status 0 or 1
- Patients with severe complication
- Patients are unable to swallow oral medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ONO-4578+ONO-4538+FOLFOX plus bevacizumab ONO-4538 - ONO-4578+ONO-4538+FOLFOX plus bevacizumab Calcium Levofolinate Hydrateb - ONO-4578+ONO-4538+XELOX plus bevacizumab ONO-4578 - ONO-4578+ONO-4538+XELOX plus bevacizumab ONO-4538 - ONO-4578+ONO-4538+FOLFOX plus bevacizumab ONO-4578 - ONO-4578+ONO-4538+XELOX plus bevacizumab Oxaliplatin - ONO-4578+ONO-4538+XELOX plus bevacizumab Capecitabine - ONO-4578+ONO-4538+XELOX plus bevacizumab Bevacizumab - ONO-4578+ONO-4538+FOLFOX plus bevacizumab Oxaliplatin - ONO-4578+ONO-4538+FOLFOX plus bevacizumab Fluorouracil - ONO-4578+ONO-4538+FOLFOX plus bevacizumab Bevacizumab -
- Primary Outcome Measures
Name Time Method Incidence and severity of AEs and SAEs up to 3years Incidence and severity of clinical laboratory abnormalities up to 3years 12-lead electrocardiography (Heart rate) up to 3years 12-lead electrocardiography (PR interval) up to 3years 12-lead electrocardiography (RR interval) up to 3years 12-lead electrocardiography (QRS width) up to 3years 12-lead electrocardiography (QT interval) up to 3years Chest X-ray test up to 3years ECOG performance status up to 3years
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) up to 3years Disease control rate (DCR) up to 3years Overall survival (OS) up to 3years Progression-free survival (PFS) up to 3years Duration of response (DOR) up to 3years Time to response (TTR) up to 3years Best oveall response (BOR) up to 3years Percentage of change in the sum of tumor diameters of target lesions up to 3years Maximum percent change in the sum diameters of the target lesions up to 3years Time course of tumor markers up to 3years Plasma ONO-4578 concentration up to 3years Serum ONO-4538 concentration up to 3years Anti-ONO-4538 antibody up to 3years
Trial Locations
- Locations (9)
Cancer Institute Hospital of JFCR
🇯🇵Koto-Ku, Tokyo, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki-shi, Osaka, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
🇯🇵Kobe-shi, Hyogo, Japan
Saitama Cancer Center
🇯🇵Ina, Kitaadati-gun, Saitama, Japan
NHO Osaka National Hospital
🇯🇵Osaka-shi, Osaka, Japan
Osaka General Medical Center
🇯🇵Osaka-shi, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka-shi, Saitama, Japan