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

Korábbi kezelés

• Concurrent illnesses that would be a relative contraindication to trial participation such as active cardiac or liver disease
• 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

Más betegség

• 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.
• Active infection or an unexplained fever >38.5°C on the first scheduled day of dosing
• History of interstitial lung disease, history of slowly progressive dyspnoea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
• Known hypersensitivity to any of the components of Onivyde injection, other liposomal products, or any components of 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

Egyéb

• Neuroendocrine tumour (carcinoid, islet cell) or acinar pancreatic carcinoma
• Known low or absent dihydropyrimidine dehydrogenase (DPD) activity.
• Homozygous for the UGT1A1*28 allele.
• 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.

• 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 known to be 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