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Trial Title:
A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer
NCT ID:
NCT06532331
Condition:
Metastatic Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Gemcitabine
Nivolumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONO-7475
Description:
Specified dose on specified days
Arm group label:
ONO-7475+GnP
Arm group label:
ONO-7475＋ONO-4538＋GnP
Intervention type:
Drug
Intervention name:
ONO-4538
Description:
Specified dose on specified days
Arm group label:
ONO-7475＋ONO-4538＋GnP
Other name:
Nivolumab
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Specified dose on specified days
Arm group label:
ONO-7475+GnP
Arm group label:
ONO-7475＋ONO-4538＋GnP
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Specified dose on specified days
Arm group label:
ONO-7475+GnP
Arm group label:
ONO-7475＋ONO-4538＋GnP
Summary:
This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination
with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety
of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as
first-line treatment
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient with metastatic pancreatic cancer
2. Patients have an ECOG performance status of 0 to 1
3. Patients with a life expectancy of at least 6 months
Exclusion Criteria:
1. Patients are unable to swallow oral medications
2. Patients with severe complication
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aichi Cancer Center
Address:
City:
Nagoya-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanazawa University Hospital
Address:
City:
Kanazawa-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Yokohama-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Seirei Hamamatsu General Hospital
Address:
City:
Hamamatsu-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Juntendo University Hpspital
Address:
City:
Bunkyo-ku
Country:
Japan
Status:
Recruiting
Facility:
Name:
The University of Tokyo Hospital
Address:
City:
Bunkyo-ku
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital Of JFCR
Address:
City:
Koto-Ku
Country:
Japan
Status:
Recruiting
Start date:
December 6, 2023
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Ono Pharmaceutical Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06532331
