A Phase 2 interventional study of Irinotecan liposome injection (S095013) and Oxaliplatin in Metastatic Adenocarcinoma of the Pancreas, sponsored by Institut de Recherches Internationales Servier. Completed at 14 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Institut de Recherches Internationales Servier · Phase 2, Interventional, and Treatment
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.
Institut de Recherches Internationales Servier is the lead sponsor of 64 studies on the registry; 5 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Irinotecan liposome injection (S095013) · Drug: Oxaliplatin · Drug: LLV (levoisomer form of leucovorin) · Drug: 5- FU (5-Fluorouracil)
Irinotecan liposome injection (S095013) will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
Also known as: MM-398, Nal-IRI, BAX2398, PEP02, liposomal irinotecan
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.
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.
Time frame: Through the end of study treatment (approximately 16 months after study start)
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Institut de Recherches Internationales Servier