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

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Servier Protocol Code: S095013-169 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT06225999

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 14 locations

Study description

This study was needed to test the study drug, called S095013, combined with the other anticancer drugs oxaliplatin, 5-fluorouracil and levoleucovorin. The study included patients with pancreatic cancer that had spread to other parts of the body (called metastatic). Pancreatic cancer affects the pancreas, an organ behind the stomach that helps with digestion and secretes hormones (chemical substances).

A previous study, called the NAPOLI 3 study, showed that this combination treatment helped patients live longer (called overall survival) compared the one of the most common treatments for pancreatic cancer: gemcitabine plus nab-paclitaxel. However, the NAPOLI 3 study did not include Japanese participants and only had a small number of Asian participants. Therefore, it was important to test this treatment in Japanese populations.

The main goal of this study was to see how effective S095013 combined with oxaliplatin, 5-fluorouracil and levoleucovorin is in treating Japanese patients with metastatic pancreatic cancer.

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
Conditions
Metastatic Adenocarcinoma of the Pancreas
Interventions / Treatments
  • Irinotecan liposome injection (S095013)
  • Oxaliplatin
  • LLV (levoisomer form of leucovorin)
  • 5- FU (5-Fluorouracil)
Other study id numbers
  • S095013-169

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants had to:

  • Be adults aged 18 or older.
  • Have confirmed metastatic pancreatic cancer and have not received any previous treatment for their metastatic cancer.
  • Have been diagnosed with metastatic cancer in the 6 weeks before starting the study.

Participants could not take part in the study if:

  • They had previously received treatment for metastatic cancer.
  • They had received anticancer medicines for their cancer in the last 12 months before starting the study.
  • Their cancer had spread to the brain or spinal cord.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: Irinotecan liposome

Injection in combination with oxaliplatin, 5-FU and LLV

Intervention / Treatment
Drug: Irinotecan liposome injection (S095013)

Participants received irinotecan liposome injection (S095013) through an IV infusion (injection given slowly) into a vein, on days 1 and 15 of each 28-day cycle

Drug: Oxaliplatin

Participants received oxaliplatin through an IV on days 1 and 15 of each 28-day cycle.

Drug: LLV (levoisomer form of leucovorin)

Participants received LLV through an IV on days 1 and 15 of each 28-day cycle.

Drug: 5-FU (5-Fluorouracil)

Participants received 5-FU through an IV on days 1 and 15 of each 28-day cycle.