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

Conditions

• Metastatic Adenocarcinoma of the Pancreas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Irinotecan liposome injection (S095013) — DRUG
  Irinotecan liposome injection (S095013) will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
• Oxaliplatin — DRUG
  Oxaliplatin will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
• LLV (levoisomer form of leucovorin) — DRUG
  LLV will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.
• 5- FU (5-Fluorouracil) — DRUG
  5-FU will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle.

Study Details

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.

Key Dates

Start date

Apr 25, 2024

Status verified

May 2026

Primary completion

Apr 28, 2025

Completion

Sep 29, 2025

Study Design

Enrollment

41 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Overall Response (OR) [ Time Frame: Through the end of study treatment (approximately 16 months after study start) ]