ONO-4578-02:ONO-4578 Phase 1 Study

JRCT ID: jRCT2031200215

Registered date:25/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable colorectal cancer
• Date of first enrollment: 13/01/2021
• Target sample size: 36
• Study type: Interventional
• Intervention(s): ONO-4578 given as combinations of ONO-4578, ONO-4538, XELOX plus bevacizumab or FOLFOX plus bevacizumab

Outcome(s)

• Primary Outcome: Safety, tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Unresectable colorectal cancer
2. Life expectancy of at least 3 months
3. Patients with ECOG performance status 0 or 1

Exclude criteria

1. Patients with severe complication
2. Patients are unable to swallow oral medications

Related Information

• Primary Sponsor: Hirashima Yoshinori