A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination With Anti-Cancer Agents in Adult Participants With Metastatic Pancreatic Adenocarcinoma (SIRACUSA)

  • STATUS
    Recruiting
  • End date
    Sep 14, 2023
  • participants needed
    88
  • sponsor
    Ipsen
Updated on 14 October 2022

Summary

The aim of this study is to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas. Adult participants with metastatic pancreatic adenocarcinoma will receive Test Product (TP) and Reference Product (RP) Onivyde in line with its approved indication. The order in which they receive them depends on the group to which they are randomly assigned, this will be referred to as the crossover phase. The average study duration for each participant until end of crossover phase is estimated to be approximately 3 months. After completion of the crossover phase, participants who in the opinion of the investigator will benefit from the treatment will be offered to enter the extension phase where they will receive the commercial Onivyde (RP) until disease progression, withdrawal, unacceptable toxicity or death. Metastatic pancreatic adenocarcinoma is a cancer that has spread (metastasized) beyond the area of the pancreas to other organs of the body. Onivyde is approved for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with 5-flurouracil (5-FU) and leucovorin (LV).

Details
Condition Metastatic Pancreatic Adenocarcinoma
Treatment 5-fluorouracil, Folinic Acid, Irinotecan liposome injection
Clinical Study IdentifierNCT05383352
SponsorIpsen
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

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 UGT1A128 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
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