Who is sponsoring NCT06225999?

NCT06225999 is sponsored by Institut de Recherches Internationales Servier.

What drugs are being tested in NCT06225999?

Interventions in NCT06225999: Irinotecan liposome injection (S095013), Oxaliplatin, LLV (levoisomer form of leucovorin), 5- FU (5-Fluorouracil).

What condition does NCT06225999 study?

NCT06225999 studies Metastatic Adenocarcinoma of the Pancreas.

Is NCT06225999 still recruiting?

NCT06225999 is currently active, enrolled. Last updated 8 October 2024.

Last reviewed 2024-10-08 · How we verify

NCT06225999

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 2 Last updated 8 October 2024

What this trial tests

Phase 2 trial testing Irinotecan liposome injection (S095013) in Metastatic Adenocarcinoma of the Pancreas in 41 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 April 2024

Primary endpoint
28 August 2025

1 January 2026

Quick facts

Lead sponsor	Institut de Recherches Internationales Servier
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	25 April 2024
Primary completion	28 August 2025
Estimated completion	1 January 2026
Sites	14 locations across Japan

Drugs / interventions tested

Irinotecan liposome injection (S095013) — full drug profile →
Oxaliplatin (Oxaliplatin) — full drug profile →
LLV (levoisomer form of leucovorin) — full drug profile →
5- FU (5-Fluorouracil)

Conditions studied

Metastatic Adenocarcinoma of the Pancreas — all drugs for Metastatic Adenocarcinoma of the Pancreas →

Sponsor

Institut de Recherches Internationales Servier — full company profile →

Who can join

18 and older, any sex, with Metastatic Adenocarcinoma of the Pancreas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

NALIRIFOX in Japanese treatment-naïve patients with metastatic pancreatic adenocarcinoma: an open-label, phase II trial design.
Ikeda M, Okusaka T, Ueno M, Ozaka M, et al · · 2025 · PMID 39987459 · DOI 10.1080/14796694.2025.2469467

Verify or expand the search:

Other recruiting trials for Metastatic Adenocarcinoma of the Pancreas

Currently open trials in the same condition.

NCT06867497 — A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and · Phase 1 · recruiting

Other Institut de Recherches Internationales Servier trials

Trials by the same sponsor.

NCT07227857 — A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopath · Phase 1, PHASE2 · recruiting
NCT06501625 — Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Meta · Phase 1, PHASE2 · recruiting
NCT06465953 — Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelod · Phase 3 · recruiting
NCT05674474 — A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hep · Phase 1 · completed
NCT05484622 — Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma · Phase 1 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06225999 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institut de Recherches Internationales Servier
Last refreshed: 8 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06225999.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing