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

NCT ID: NCT06547385

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ONO-4578+ONO-4538+XELOX plus bevacizumab

Group Type EXPERIMENTAL

ONO-4578

Intervention Type DRUG

Specified dose on specified days

ONO-4538

Intervention Type DRUG

Specified dose on specified days

Capecitabine

Intervention Type DRUG

Specified dose on specified days

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

ONO-4578+ONO-4538+FOLFOX plus bevacizumab

Group Type EXPERIMENTAL

ONO-4578

Intervention Type DRUG

Specified dose on specified days

ONO-4538

Intervention Type DRUG

Specified dose on specified days

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Calcium Levofolinate Hydrateb

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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ONO-4578

Specified dose on specified days

Intervention Type DRUG

ONO-4538

Specified dose on specified days

Intervention Type DRUG

Capecitabine

Specified dose on specified days

Intervention Type DRUG

Oxaliplatin

Specified dose on specified days

Intervention Type DRUG

Fluorouracil

Specified dose on specified days

Intervention Type DRUG

Calcium Levofolinate Hydrateb

Specified dose on specified days

Intervention Type DRUG

Bevacizumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Nivolumab XELODA ELPLAT 5-FU ISOVORIN AVASTIN

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Site Status

Kobe City Hospital Organization Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status

Saitama Cancer Center

Ina, Kitaadati-gun, Saitama, Japan

Site Status

NHO Osaka National Hospital

Osaka, Osaka, Japan

Site Status

Osaka General Medical Center

Osaka, Osaka, Japan

Site Status

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-shi, Osaka, Japan

Site Status

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, Japan

Site Status

Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-4578-02

Identifier Type: -

Identifier Source: org_study_id

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