Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas
A Single-arm Multicentre Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Who Have Not Previously Received Therapy for Metastatic Adenocarcinoma of the Pancreas
1 other identifier
interventional
41
1 country
14
Brief Summary
This study is to assess the anti-tumour activity, safety and tolerability of irinotecan liposome injection (S095013) in combination with oxaliplatin, 5-Fluorouracil (5-FU) and levoisomer form of leucovorin (LLV). S095013, oxaliplatin, 5-FU and LLV will be administered on days 1 and 15 of each 28-day cycle. Cycles will continue until clinical or radiological progressive disease, unacceptable study medication-related toxicity or withdrawal from study. During the treatment period participants will have study visits on day 1, 3, 15, and 17 of each cycle, some of which may occur as a home visit. At least 30 days after treatment has ended a end of treatment visit will occur and then participants will be followed for survival every month via telephone or email until death or end of the study. Study visits may include questionnaires, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2024
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2024
CompletedFirst Posted
Study publicly available on registry
January 26, 2024
CompletedStudy Start
First participant enrolled
April 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2025
CompletedMay 4, 2026
April 1, 2026
1 year
January 17, 2024
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response (OR)
OR is defined as complete response (CR) or partial response (PR), as assessed by the independent central review (ICR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Through the end of study treatment (approximately 16 months after study start)
Study Arms (1)
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV
EXPERIMENTALInterventions
Irinotecan liposome injection (S095013) will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
Oxaliplatin will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
LLV will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
5-FU will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Male or non-pregnant and non-lactating female ≥ 18 years of age.
- Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
- Initial diagnosis of metastatic disease (as per American Joint Committee on Cancer 8th Edition \[AJCC 2017\]) must have occurred ≤ 6 weeks prior to screening.
- Participant has one or more metastatic lesions measurable by CT-scan (or MRI), if the participant is allergic to CT contrast media, according to RECIST Version 1.1 criteria.
- ECOG PS of 0 or 1 at screening and within 7 days prior to first dosing.
- Participant has adequate hematological, biochemical, hepatic, and renal function parameters.
You may not qualify if:
- Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy (palliative surgery, palliative radiotherapy and placement of biliary stent/tube are permitted).
- Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related relevant toxicities are present.
- Participant has only locally advanced disease.
- Known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or any components of 5-FU, LLV or oxaliplatin products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
National Cancer Center Hospital East (003)
Kashiwa, Chiba, 277-8577, Japan
Chiba University Hospital (015)
Chiba, 260-8677, Japan
Chiba Cancer Center (011)
Chiba, 260-8717, Japan
National Hospital Organization Shikoku Cancer Center (013)
Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center (005)
Fukuoka, 811-1395, Japan
Kanazawa University Hospital (008)
Ishikawa, 920-8641, Japan
Kanagawa Cancer Center (002)
Kanagawa, 241-8515, Japan
Aichi Cancer Center (007)
Nagoya, 464-8681, Japan
Osaka International Cancer Institute (009)
Osaka, 541-8567, Japan
Saitama Cancer Center (012)
Saitama, 362-0806, Japan
Hokkaido University Hospital (004)
Sapporo, 060-8648, Japan
National Cancer Center Hospital (001)
Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR (006)
Tokyo, 135-8550, Japan
Yamaguchi University Hospital (010)
Yamaguchi, 755-8505, Japan
Related Publications (1)
Ikeda M, Okusaka T, Ueno M, Ozaka M, Satoi S, Skanji D, Martin-Fernandez L, Amellal N, Furuse J. NALIRIFOX in Japanese treatment-naive patients with metastatic pancreatic adenocarcinoma: an open-label, phase II trial design. Future Oncol. 2025 Apr;21(8):959-965. doi: 10.1080/14796694.2025.2469467. Epub 2025 Feb 22.
PMID: 39987459DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2024
First Posted
January 26, 2024
Study Start
April 25, 2024
Primary Completion
April 28, 2025
Study Completion
September 29, 2025
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorization in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.