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ACTIVE NOT RECRUITING
NCT06547385
PHASE1

Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer

Sponsor: Ono Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

ONO-4578

Specified dose on specified days

DRUG

ONO-4538

Specified dose on specified days

DRUG

Capecitabine

Specified dose on specified days

DRUG

Oxaliplatin

Specified dose on specified days

DRUG

Fluorouracil

Specified dose on specified days

DRUG

Calcium Levofolinate Hydrateb

Specified dose on specified days

DRUG

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