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

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: Fluorouracil; Drug: Calcium Levofolinate Hydrateb; Drug: ONO-4538; Drug: Capecitabine; Drug: ONO-4578; Drug: Bevacizumab; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06547385

ONO-4578-02

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

ONO-4578+ONO-4538+XELOX plus bevacizumab

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: Bevacizumab

Drug: ONO-4578

Drug: Capecitabine

Drug: ONO-4538

ONO-4578+ONO-4538+FOLFOX plus bevacizumab

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: Bevacizumab

Drug: ONO-4578

Drug: ONO-4538

Drug: Calcium Levofolinate Hydrateb

Drug: Fluorouracil