A study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/levoleucovorin in Japanese participants that have not been treated for pancreatic cancer that has spread (metastatic)

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230733

Enrollment

Registered

2024-03-27

Start date

2024-03-31

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Adenocarcinoma of the Pancreas Pancreatic cancer

Interventions

Drug: Irinotecan liposome injection (S095013) Irinotecan liposome injection (S095013) will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. Other Names: MM-398 Nal

D007262

Intravenous Infusions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Overall Response (OR)	—

Secondary

Measure	Time frame
- Duration of Response (DoR) - Time to Response (TTR) - Disease Control Rate (DCR) - Progression Free Survival (PFS) - Overall Survival (OS) - Safety - PK - QoL	—

Contacts

Public Contactclinical operation department International center for therapeutic research

Nihon Servier Company Limited

clinicaltrials.jpn@servier.com+81-3-5842-7111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026