Status:
COMPLETED
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients wi...
Eligibility Criteria
Inclusion
- 1\. Pancreatic invasive ducatal adenocarcinoma
- 2\. Life expectancy of at least 3 months
- 3\. Patients with ECOG performance status 0 or 1
Exclusion
- 1\. Patients with severe complication
- 2\. Patients with multiple primary cancers
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06538207
Start Date
January 13 2021
End Date
January 30 2025
Last Update
February 6 2025
Active Locations (9)
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1
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
2
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
3
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
4
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan