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
NCT ID: NCT06538207
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2021-01-13
2025-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ONO-4578+ONO-4538+mFFX
ONO-4578
Specified dose on specified days
ONO-4538
Specified dose on specified days
Oxaliplatin
Specified dose on specified days
Levofolinate
Specified dose on specified days
Irinotecan
Specified dose on specified days
Fluorouracil
Specified dose on specified days
ONO-4578+ONO-4538+GnP
ONO-4578
Specified dose on specified days
ONO-4538
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Nab-Paclitaxel
Specified dose on specified days
Interventions
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ONO-4578
Specified dose on specified days
ONO-4538
Specified dose on specified days
Oxaliplatin
Specified dose on specified days
Levofolinate
Specified dose on specified days
Irinotecan
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Nab-Paclitaxel
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\. Life expectancy of at least 3 months
* 3\. Patients with ECOG performance status 0 or 1
Exclusion Criteria
* 2\. Patients with multiple primary cancers
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Countries
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Other Identifiers
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jRCT2031200286
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-4578-04
Identifier Type: -
Identifier Source: org_study_id
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