An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer
NCT ID: NCT06532344
Last Updated: 2024-11-14
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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ACTIVE_NOT_RECRUITING
PHASE1
32 participants
INTERVENTIONAL
2021-07-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ONO-7913+ONO-4538+mFFX
ONO-7913
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
Interventions
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ONO-7913
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
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
The Cancer Institute Hospital ofJFCR
Koto-ku, Tokyo, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
National Cancer Center Hospital
Chūōku, , Japan
Countries
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Other Identifiers
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ONO-7913-03
Identifier Type: -
Identifier Source: org_study_id
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