NCT06225999

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Adenocarcinoma of the Pancreas

Interventions

Type	Name	Description
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.
DRUG	Oxaliplatin	Oxaliplatin will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
DRUG	LLV (levoisomer form of leucovorin)	LLV will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
DRUG	5- FU (5-Fluorouracil)	5-FU will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

Timeline

• Start date: 2024-04-25
• Primary completion: 2025-08-28
• Completion: 2026-01-01
• First posted: 2024-01-26
• Last updated: 2024-10-08

Locations

14 sites across 1 country: Japan