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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

April 25, 2024

Primary Completion Date

August 28, 2025

Study Completion Date

January 1, 2026

Conditions
Metastatic Adenocarcinoma of the Pancreas
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.

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.

Trial Locations (14)

277-8577

National Cancer Center Hospital East (003), Kashiwa

260-8677

Chiba University Hospital (015), Chiba

260-8717

Chiba Cancer Center (011), Chiba

791-0280

National Hospital Organization Shikoku Cancer Center (013), Ehime

811-1395

National Hospital Organization Kyushu Cancer Center (005), Fukuoka

920-8641

Kanazawa University Hospital (008), Ishikawa

241-8515

Kanagawa Cancer Center (002), Kanagawa

464-8681

Aichi Cancer Center (007), Nagoya

541-8567

Osaka International Cancer Institute (009), Osaka

362-0806

Saitama Cancer Center (012), Saitama

060-8648

Hokkaido University Hospital (004), Sapporo

104-0045

National Cancer Center Hospital (001), Tokyo

135-8550

The Cancer Institute Hospital of JFCR (006), Tokyo

755-8505

Yamaguchi University Hospital (010), Yamaguchi

All Listed Sponsors
lead

Institut de Recherches Internationales Servier

OTHER

NCT06225999 - Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas | Biotech Hunter | Biotech Hunter