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Completed

NCT Number: NCT06225999

Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas

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.

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Key information

Conditions

Metastatic Adenocarcinoma of the Pancreas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center Hospital East (003), Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Irinotecan liposome injection (S095013)

Drug

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-IRI, BAX2398, PEP02, liposomal irinotecan

Oxaliplatin

Drug

Oxaliplatin will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

LLV (levoisomer form of leucovorin)

Drug

LLV will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

5- FU (5-Fluorouracil)

Drug

5-FU will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

Primary outcomes

  1. Overall Response (OR)

    Time frame: Through the end of study treatment (approximately 16 months after study start)

    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.

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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