Colorectal Cancer
Conditions
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.
Interventions
DRUGONO-4578
Specified dose on specified days
DRUGONO-4538
Specified dose on specified days
DRUGCapecitabine
Specified dose on specified days
DRUGOxaliplatin
Specified dose on specified days
DRUGFluorouracil
Specified dose on specified days
DRUGCalcium Levofolinate Hydrateb
Specified dose on specified days
DRUGBevacizumab
Specified dose on specified days
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unresectable colorectal cancer * Life expectancy of at least 3 months * Patients with ECOG performance status 0 or 1
Exclusion criteria
* Patients with severe complication * Patients are unable to swallow oral medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Contacts
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed