Phase 2 Study Of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin In Japanese Participants Not Previously Treated For Metastatic Adenocarcinoma Of The Pancreas

Study Overview

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

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.

N/A

Metastatic Adenocarcinoma of the Pancreas

DRUG: Irinotecan liposome injection (S095013)
DRUG: Oxaliplatin
DRUG: LLV (levoisomer form of leucovorin)
DRUG: 5- FU (5-Fluorouracil)

S095013-169

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-01-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-10-03
First Submitted that Met QC Criteria 2024-01-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-08
First Posted (ACTUAL) 2024-01-26	Results First Posted N/A	Last Verified 2024-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV	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.

Participant Group/Arm

Intervention/Treatment

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

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.

Primary Outcome Measures	Measure Description	Time Frame
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)

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record