NCT06547385PHASE1ACTIVE_NOT_RECRUITING

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

Sponsor: Ono Pharmaceutical Co., Ltd.

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Colorectal Cancer

Interventions

ONO-4578, ONO-4538, Capecitabine, Oxaliplatin

Enrollment

40 participants

Primary completion

Oct 2027

Study completion

Oct 2027

First posted

Aug 2024

Last updated

Aug 2024

Primary Endpoints (CT.gov)

Incidence and severity of AEs and SAEs

Time frame: up to 3years

Incidence and severity of clinical laboratory abnormalities

Time frame: up to 3years

12-lead electrocardiography (Heart rate)

Time frame: up to 3years

12-lead electrocardiography (PR interval)

Time frame: up to 3years

Secondary Endpoints

Objective response rate (ORR)

Disease control rate (DCR)

Overall survival (OS)

Eligibility Criteria

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

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov