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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
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.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Saitama Cancer Center
Ina, Kitaadati-gun, Saitama, Japan
NHO Osaka National Hospital
Osaka, Osaka, Japan
Osaka General Medical Center
Osaka, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Start Date
January 13, 2021
Primary Completion Date
October 31, 2027
Completion Date
October 31, 2027
Last Updated
August 9, 2024
40
ACTUAL participants
ONO-4578
DRUG
ONO-4538
DRUG
Capecitabine
DRUG
Oxaliplatin
DRUG
Fluorouracil
DRUG
Calcium Levofolinate Hydrateb
DRUG
Bevacizumab
DRUG
Lead Sponsor
Ono Pharmaceutical Co. Ltd
NCT04704661
NCT06696768
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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