A study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/levoleucovorin in Japanese participants that have not been treated for pancreatic cancer that has spread (metastatic)

JRCT ID: jRCT2031230733

Registered date:27/03/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Adenocarcinoma of the Pancreas
• Date of first enrollment: 31/03/2024
• Target sample size: 41
• Study type: Interventional

Intervention(s)

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.

Other Names:
MM-398
Nal-IRI
BAX2398
PEP02
liposomal irinotecan
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.

Outcome(s)

• Primary Outcome: Overall Response (OR)

Secondary Outcome

- Duration of Response (DoR)
- Time to Response (TTR)
- Disease Control Rate (DCR)
- Progression Free Survival (PFS)
- Overall Survival (OS)
- Safety
- PK
- QoL

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 Information

• Primary Sponsor: Fernandez Martin Lourdes
• Secondary ID(s): NCT06225999