ONO-4578-04:ONO-4578 Phase 1 Study

JRCT ID: jRCT2031200286

Registered date:06/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: metastatic pancreatic cancer
• Date of first enrollment: 13/01/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): ONO-4578 given as combinations of ONO-4578, ONO-4538 and modified FOLFIRINOX or Gem/nab-PTX

Outcome(s)

• Primary Outcome: Safety, tolerability

Key inclusion & exclusion criteria

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

Include criteria

1. Pancreatic invasive ducatal adenocarcinoma
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 with multiple primary cancers

Related Information

• Primary Sponsor: Namba Yoshinobu
• Secondary ID(s): NCT06538207