A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas (SIRACUSA)

This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma Read More

Inclusion Criteria :

• Participant must be ≥18 years of age at the time of signing the informed consent.
• Participants who have histological or cytologically confirmed adenocarcinoma of the pancreas.
• Participants with an initial diagnosis of progressive metastatic disease
• Participants with a confirmed diagnosis of metastatic adenocarcinoma of the pancreas with disease progression following gemcitabine-based therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
• Adequate haematological parameters
• Adequate hepatic function
• Adequate renal function
• Adequate coagulation
• No clinically significant abnormalities in urinalysis results
• Electrocardiogram (ECG) without any clinically significant findings
• Participants infected with controlled human immunodeficiency virus (HIV)
• Male and female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Capable of giving signed informed consent

Exclusion Criteria :

• Have only localised advanced disease.
• History of any second malignancy in the last 2 years.
• Known history of central nervous system metastases
• Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, diarrhoea >Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.
• Concurrent illnesses that would be a relative contraindication to trial participation such as active cardiac or liver disease
• Active infection or an unexplained fever >38.5°C during screening visits or on the first scheduled day of dosing
• Neuroendocrine tumour (carcinoid, islet cell) or acinar pancreatic carcinoma
• History of interstitial lung disease, history of slowly progressive dyspnoea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
• Exposure to a non-liposomal irinotecan or SN-38 based regimen within 4 weeks prior to randomisation, or exposure to Onivyde or other irinotecan based liposomal products within 6 weeks prior to randomisation
• Major surgery, other than diagnostic surgery, within 4 weeks prior to randomisation
• Participants who have received a live vaccine within 4 weeks prior to randomisation.
• Use of strong CYP3A inhibitors or inducers, or strong inhibitors of UGT1A1.
• Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to study intervention on Cycle 1 Day 1
• Known low or absent dihydropyrimidine dehydrogenase (DPD) activity.
• Homozygous for the UGT1A1*28 allele.
• Known hypersensitivity to any of the components of Onivyde injection, other liposomal products, or any components of 5-FU, or LV
• Presence of any contraindications outlined in the Contraindications or Warnings and Precautions sections of the IB for Onivyde, or in the prescribing information for 5-FU or LV.
• Participants who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening
• Any other medical or social condition deemed by the investigator to be likely to interfere with a participant's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results