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

Metastatic Adenocarcinoma of the Pancreas Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06225999
• Other study ID #: S095013-169
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 31, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Servier
• Contact: Institut de Recherches Internationales Servier (I.R.I.S.), Clini
• Phone: +33 1 55 72 60 00
• Email: scientificinformation[@]servier.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 41
• Est. completion date: January 1, 2026
• Est. primary completion date: August 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Adenocarcinoma of the Pancreas

Intervention

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

Locations

Country	Name	City	State
Japan	Chiba Cancer Center (011)	Chiba
Japan	Chiba University Hospital (015)	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	JPN-003	Jpn-003
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	Kyorin University Hospital (014)	Tokyo
Japan	National Cancer Center Hospital (001)	Tokyo
Japan	The Cancer Institute Hospital of JFCR (006)	Tokyo
Japan	Yamaguchi University Hospital (010)	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response (OR)	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.	Through the end of study treatment (approximately 16 months after study start)