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

NCT06547385 · tracked via the Priya Life Science Japan tracker

Sponsor

Ono Pharmaceutical Co., Ltd

Phase

Phase 1

Started

2021-01-13

Last updated

2024-08-09

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

ONO-4578 →ONO-4538 →Capecitabine →Oxaliplatin →Fluorouracil →Calcium Levofolinate Hydrateb →Bevacizumab →

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

Study 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.

Eligibility

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (9)

Facility	City	Region
National Cancer Center Hospital East	Kashiwa-shi	Chiba
Kobe City Hospital Organization Kobe City Medical Center General Hospital	Kobe	Hyōgo
Kanagawa Cancer Center	Yokohama	Kanagawa
Saitama Cancer Center	Ina	Kitaadati-gun, Saitama
NHO Osaka National Hospital	Osaka	Osaka
Osaka General Medical Center	Osaka	Osaka
Osaka Medical and Pharmaceutical University Hospital	Takatsuki-shi	Osaka
Saitama Medical University International Medical Center	Hidaka-shi	Saitama
Cancer Institute Hospital of JFCR	Koto-Ku	Tokyo

On this site

📄 Avastin (bevacizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06547385 on ClinicalTrials.gov ↗ ← All trials in Japan