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Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
Sponsor: Ono Pharmaceutical Co. Ltd
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.
Official title: 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
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2021-01-13
Completion Date
2027-10-31
Last Updated
2024-08-09
Healthy Volunteers
No
Conditions
Interventions
ONO-4578
Specified dose on specified days
ONO-4538
Specified dose on specified days
Capecitabine
Specified dose on specified days
Oxaliplatin
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Calcium Levofolinate Hydrateb
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Locations (9)
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