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Trial Title:
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
NCT ID:
NCT06547385
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Leucovorin
Bevacizumab
Nivolumab
Capecitabine
Oxaliplatin
Fluorouracil
Calcium
Levoleucovorin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONO-4578
Description:
Specified dose on specified days
Arm group label:
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
Arm group label:
ONO-4578+ONO-4538+XELOX plus bevacizumab
Intervention type:
Drug
Intervention name:
ONO-4538
Description:
Specified dose on specified days
Arm group label:
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
Arm group label:
ONO-4578+ONO-4538+XELOX plus bevacizumab
Other name:
Nivolumab
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Specified dose on specified days
Arm group label:
ONO-4578+ONO-4538+XELOX plus bevacizumab
Other name:
XELODA
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Specified dose on specified days
Arm group label:
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
Arm group label:
ONO-4578+ONO-4538+XELOX plus bevacizumab
Other name:
ELPLAT
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
Specified dose on specified days
Arm group label:
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
Other name:
5-FU
Intervention type:
Drug
Intervention name:
Calcium Levofolinate Hydrateb
Description:
Specified dose on specified days
Arm group label:
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
Other name:
ISOVORIN
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Specified dose on specified days
Arm group label:
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
Arm group label:
ONO-4578+ONO-4538+XELOX plus bevacizumab
Other name:
AVASTIN
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Country:
Japan
Facility:
Name:
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Address:
City:
Kobe-shi
Country:
Japan
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Yokohama-shi
Country:
Japan
Facility:
Name:
Saitama Cancer Center
Address:
City:
Ina
Country:
Japan
Facility:
Name:
NHO Osaka National Hospital
Address:
City:
Osaka-shi
Country:
Japan
Facility:
Name:
Osaka General Medical Center
Address:
City:
Osaka-shi
Country:
Japan
Facility:
Name:
Osaka Medical and Pharmaceutical University Hospital
Address:
City:
Takatsuki-shi
Country:
Japan
Facility:
Name:
Saitama Medical University International Medical Center
Address:
City:
Hidaka-shi
Country:
Japan
Facility:
Name:
Cancer Institute Hospital of JFCR
Address:
City:
Koto-Ku
Country:
Japan
Start date:
January 13, 2021
Completion date:
October 31, 2027
Lead sponsor:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Ono Pharmaceutical Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06547385
