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

NCT ID: NCT06225999

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-25
• Study Completion Date: 2026-01-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV

Group Type: EXPERIMENTAL

Irinotecan liposome injection (S095013)

Intervention Type: DRUG

Irinotecan liposome injection (S095013) will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

Oxaliplatin

Intervention Type: DRUG

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

LLV (levoisomer form of leucovorin)

Intervention Type: DRUG

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

5- FU (5-Fluorouracil)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

LLV (levoisomer form of leucovorin)

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

Intervention Type: DRUG

5- FU (5-Fluorouracil)

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

Intervention Type: DRUG

Other Intervention Names

MM-398; Nal-IRI; BAX2398; PEP02; liposomal irinotecan

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Internationales Servier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cancer Center Hospital East (003)

Kashiwa, Chiba, Japan

Chiba University Hospital (015)

Chiba, , Japan

Chiba Cancer Center (011)

Chiba, , Japan

National Hospital Organization Shikoku Cancer Center (013)

Ehime, , Japan

National Hospital Organization Kyushu Cancer Center (005)

Fukuoka, , Japan

Kanazawa University Hospital (008)

Ishikawa, , Japan

Kanagawa Cancer Center (002)

Kanagawa, , Japan

Aichi Cancer Center (007)

Nagoya, , Japan

Osaka International Cancer Institute (009)

Osaka, , Japan

Saitama Cancer Center (012)

Saitama, , Japan

Hokkaido University Hospital (004)

Sapporo, , Japan

National Cancer Center Hospital (001)

Tokyo, , Japan

The Cancer Institute Hospital of JFCR (006)

Tokyo, , Japan

Yamaguchi University Hospital (010)

Yamaguchi, , Japan

Countries

Japan

References

Ikeda M, Okusaka T, Ueno M, Ozaka M, Satoi S, Skanji D, Martin-Fernandez L, Amellal N, Furuse J. NALIRIFOX in Japanese treatment-naive patients with metastatic pancreatic adenocarcinoma: an open-label, phase II trial design. Future Oncol. 2025 Apr;21(8):959-965. doi: 10.1080/14796694.2025.2469467. Epub 2025 Feb 22.

Reference Type: DERIVED

PMID: 39987459 (View on PubMed)

Other Identifiers

S095013-169

Identifier Type: -

Identifier Source: org_study_id