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

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of treatments for patients with metastatic adenocarcinoma of the pancreas, which is a type of advanced cancer that has spread beyond the pancreas. The treatments being tested include a special formulation of irinotecan, along with two other chemotherapy drugs, oxaliplatin and 5-fluorouracil, and a supportive medication called levoleucovorin. The goal is to see how well these medications work together to fight the cancer, as well as to check how safe they are for patients.

To participate in this study, patients must be at least 18 years old and have a confirmed diagnosis of metastatic pancreatic cancer that hasn't been treated before. They should also have measurable tumors and good overall health. During the trial, participants will receive the study drugs on specific days every 28 days and will have regular check-ups that may include visits to their home. After treatment, patients will continue to be monitored for their health and well-being through monthly phone calls or emails. It's important to note that this trial is actively recruiting participants who meet the eligibility criteria, and anyone interested should discuss this opportunity with their healthcare provider.

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.