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

August 7, 2024 updated by: Ono Pharmaceutical Co. Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ONO-4578+ONO-4538+XELOX plus bevacizumab
Drug: Oxaliplatin
Specified dose on specified days
Other Names:
  • ELPLAT
Drug: Bevacizumab
Specified dose on specified days
Other Names:
  • AVASTIN
Drug: Capecitabine
Specified dose on specified days
Other Names:
  • XELODA
Drug: ONO-4538
Specified dose on specified days
Other Names:
  • Nivolumab
Drug: ONO-4578
Specified dose on specified days
Experimental: ONO-4578+ONO-4538+FOLFOX plus bevacizumab
Drug: Fluorouracil
Specified dose on specified days
Other Names:
  • 5-FU
Drug: Oxaliplatin
Specified dose on specified days
Other Names:
  • ELPLAT
Drug: Bevacizumab
Specified dose on specified days
Other Names:
  • AVASTIN
Drug: ONO-4538
Specified dose on specified days
Other Names:
  • Nivolumab
Drug: ONO-4578
Specified dose on specified days
Drug: Calcium Levofolinate Hydrateb
Specified dose on specified days
Other Names:
  • ISOVORIN

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence and severity of AEs and SAEs
Time Frame: up to 3years
up to 3years
Incidence and severity of clinical laboratory abnormalities
Time Frame: up to 3years
up to 3years
12-lead electrocardiography (Heart rate)
Time Frame: up to 3years
up to 3years
12-lead electrocardiography (PR interval)
Time Frame: up to 3years
up to 3years
12-lead electrocardiography (RR interval)
Time Frame: up to 3years
up to 3years
12-lead electrocardiography (QRS width)
Time Frame: up to 3years
up to 3years
12-lead electrocardiography (QT interval)
Time Frame: up to 3years
up to 3years
Chest X-ray test
Time Frame: up to 3years
up to 3years
ECOG performance status
Time Frame: up to 3years
up to 3years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: up to 3years
up to 3years
Objective response rate (ORR)
Time Frame: up to 3years
up to 3years
Disease control rate (DCR)
Time Frame: up to 3years
up to 3years
Progression-free survival (PFS)
Time Frame: up to 3years
up to 3years
Duration of response (DOR)
Time Frame: up to 3years
up to 3years
Time to response (TTR)
Time Frame: up to 3years
up to 3years
Best oveall response (BOR)
Time Frame: up to 3years
up to 3years
Percentage of change in the sum of tumor diameters of target lesions
Time Frame: up to 3years
up to 3years
Maximum percent change in the sum diameters of the target lesions
Time Frame: up to 3years
up to 3years
Time course of tumor markers
Time Frame: up to 3years
up to 3years
Plasma ONO-4578 concentration
Time Frame: up to 3years
up to 3years
Serum ONO-4538 concentration
Time Frame: up to 3years
up to 3years
Anti-ONO-4538 antibody
Time Frame: up to 3years
up to 3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ono Pharmaceutical Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONO-4578-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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