Search / Trial NCT06225999

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

Launched by INSTITUT DE RECHERCHES INTERNATIONALES SERVIER · Jan 17, 2024

Trial Information

Current as of October 07, 2024

Unknown status

Keywords

Description

No description provided

Gender

ALL

Eligibility criteria

  • 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.

About Institut De Recherches Internationales Servier

Institut de Recherches Internationales Servier is a leading independent international pharmaceutical company based in France, dedicated to advancing medical research and developing innovative therapeutic solutions. With a strong focus on areas such as cardiology, diabetes, oncology, and neuropsychiatry, Servier is committed to improving patient outcomes through rigorous clinical trials and collaboration with healthcare professionals worldwide. The organization emphasizes a patient-centric approach and invests significantly in research and development, striving to address unmet medical needs and enhance the quality of life for patients globally.

Locations

Chiba, , Japan

Chiba, , Japan

Chiba, , Japan

Ehime, , Japan

Fukuoka, , Japan

Ishikawa, , Japan

Kanagawa, , Japan

Nagoya, , Japan

Osaka, , Japan

Saitama, , Japan

Sapporo, , Japan

Tokyo, , Japan

Tokyo, , Japan

Tokyo, , Japan

Yamaguchi, , Japan

Jpn 003, , Japan

Yokohama, Kanagawa, Japan

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0