Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ipsen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Have only localised advanced disease.
History of any second malignancy in the last 2 years.
Known history of central nervous system metastases
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 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
Clareo Health | A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas
