NCT06547385|Active Not RecruitingPhase 1DMC

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

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

Ono Pharmaceutical Co. Ltd ClinicalTrials.gov

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1 other identifier

ONO-4578-02

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2024

StartedJan 2021

CompletionOct 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline

18mo left

Started Jan 2021

Longer than P75 for phase_1 colorectal-cancer

Geographic Reach

1 country

9 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Progress78%

Jan 2021Oct 2027

Study Start

First participant enrolled

January 13, 2021

Completed

3.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2024

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

6.8 years

First QC Date

August 1, 2024

Last Update Submit

August 7, 2024

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (9)

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

Secondary Outcomes (13)

Objective response rate (ORR)
up to 3years
Disease control rate (DCR)
up to 3years
Overall survival (OS)
up to 3years
Progression-free survival (PFS)
up to 3years
Duration of response (DOR)
up to 3years
+8 more secondary outcomes

Study Arms (2)

ONO-4578+ONO-4538+XELOX plus bevacizumab

EXPERIMENTAL

Drug: ONO-4578Drug: ONO-4538Drug: CapecitabineDrug: OxaliplatinDrug: Bevacizumab

ONO-4578+ONO-4538+FOLFOX plus bevacizumab

EXPERIMENTAL

Drug: ONO-4578Drug: ONO-4538Drug: OxaliplatinDrug: FluorouracilDrug: Calcium Levofolinate HydratebDrug: Bevacizumab