Metastatic Pancreatic AdenocarcinomaPhase 1SIRACUSANCT05383352
A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas
A Phase 1 study testing Irinotecan liposome injection, Folinic Acid and 5-Fluorouracil in people with Metastatic Pancreatic Adenocarcinoma, run by Ipsen at 36 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Irinotecan liposome injection, Folinic Acid and 5-Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 30 May 2022to 15 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 on the first scheduled day of dosing
Show all 19Show fewer
- 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
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
Spain14 sites
Chuac Hospital Teresa Herrera
A Coruña
Hospital Universitario de Badajoz
Badajoz
Hospital Universitario Vall D Hebron
Barcelona
Instituto Oncologico Dr Rosell Lor
Barcelona
Hospital Universitari de Lleida Arnaud de Villanova
Lleida
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario Quiron Salud
Madrid, 28223
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Md Anserson Cancer Center
Madrid
Clinica Universidad de Navarra
Pamplona
Hospital Universitario Marques de Valdecilla
Santander
Complejo Hospitalario Universitario de Santiago de Compostela -Chus
Santiago de Compostela
Italy6 sites
AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna
Bologna
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola
Instituto Europeo di Oncologia
Milan
Azienda Ospedaliero Universitaria Modena
Modena
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Torrette
Ospedale Borgo Roma
Verona
France5 sites
Institut BERGONIE Centre de Lutte Contre le Cancer
Bordeaux
Centre GEORGES FRANÇOIS LECLERC
Dijon
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Chu La Miletrie
Poitiers
Centre PAUL STRAUSS
Strasbourg
Germany3 sites
University Hospital Dresden
Dresden
Asklepios Klinik Altona
Hamburg, 22763
Caritasklinikum Saarbruecken St Theresia
Saarbrücken, 66113
Hungary3 sites
Mav Korhaz Es Kozponti Rendelointezet
Budapest
Semmelweis Egyetem
Budapest
Clinexpert Kft Fázis I. Vizsgálóhely
Gyöngyös
Portugal3 sites
Hospital Senhora Da Oliveira - Hso-Epe
Guimarães
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
Lisbon
Fundacao Champalimaud
Lisbon
Australia2 sites
Flinders Medical Centre
Bedford Park
Peninsula and Southeast Oncology - Frankston Private Hospital
Frankston
About this study
Official title: 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
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.
Read more
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-fluorouracil (5-FU) and leucovorin (LV).
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- Irinotecan liposome injection, Folinic Acid, 5-Fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome injectionDrug
Also called Onivyde® Reference product
Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)
Irinotecan liposome injectionDrug
Also called Onivyde Test product
Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase)
Irinotecan liposome injectionDrug
Also called Onivyde Test product
Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase)
Irinotecan liposome injectionDrug
Also called Onivyde® Reference product
Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)
Folinic AcidDrug
Also called Leucovorin (LV)
LV 400 mg/m2 intravenously over 30 minutes, on Day 1 and Day 15 of every 28-day cycle
5-FluorouracilDrug
Also called 5-FU
5-FU 2,400 mg/m2 intravenously over 46 hours, on Day 1 and Day 15 every 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Sequence RT: Reference Product followed by Test Product | Experimental | Cycle 1 (Crossover Phase) Day 1: One dose Onivyde® Reference product + 5-FU/LV.
Cycle 1 (Crossover Phase) Day 15: One dose Onivyde Test product + 5-FU/LV
Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV Receives: Drug: Irinotecan liposome injection; Drug: Folinic Acid; Drug: 5-Fluorouracil |
| Sequence TR: Test Product followed by Reference Product | Experimental | Cycle 1 (Crossover Phase) Day 1: One dose Onivyde Test product + 5-FU/LV.
Cycle 1 (Crossover Phase) Day 15: One dose Onivyde® Reference product + 5-FU/LV.
Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV. Receives: Drug: Irinotecan liposome injection; Drug: Folinic Acid; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum (peak) plasma drug concentration (Cmax) of encapsulated irinotecan for Test relative to and Reference product
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Area under the plasma concentration-time curve from time 0 to time t (AUC(0-t) of encapsulated irinotecan for Test relative to Reference product
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞) of encapsulated irinotecan for Test relative to Reference product
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Secondary outcomes (10)
Maximum (peak) plasma drug concentration (Cmax) of total irinotecan for Test relative to Reference product
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Area under the plasma concentration-time curve from time 0 to time t (AUC(0-t)) of total irinotecan for Test relative to Reference product
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞)) of total irinotecan for Test relative to Reference product
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Time to maximum plasma concentration (Tmax) of encapsulated and total irinotecan over 15-days for each Test and Reference products
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Apparent clearance of drug from plasma (CL) of encapsulated and total irinotecan for Test and Reference products
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Apparent volume of distribution (VZ) of encapsulated and total irinotecan for Test and Reference products
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Terminal half-life (t1/2) of encapsulated and total irinotecan for Test and Reference products
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Apparent terminal elimination rate constant (λZ) of encapsulated and total irinotecan for Test and Reference products
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Percentage of participants with treatment-emergent adverse events (TEAEs) treatment-related leading to discontinuations, or to death
Including treatment-emergent serious adverse events
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Percentage of participants with clinically significant abnormal values
It includes clinically significant abnormal laboratory results, physical examination findings, Electrocardiogram (ECG) and vital signs
Measured: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start30 May 2022
- Primary completion27 May 2024
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383352
- Sponsor's protocol ID
- D-FR-60010-015
- Other IDs
- 2021-003264-26
- Acronym
- SIRACUSA
- Status last verified
- Apr 2025
- First submitted
- 3 May 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05383352
- Acronym / sponsor ID
- SIRACUSA / D-FR-60010-015
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-fluorouracil (5-FU) and leucovorin (LV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence RT: Reference Product followed by Test Product | Experimental | Drug: Irinotecan liposome injection, Drug: Folinic Acid, Drug: 5-FluorouracilCycle 1 (Crossover Phase) Day 1: One dose Onivyde® Reference product + 5-FU/LV. Cycle 1 (Crossover Phase) Day 15: One dose Onivyde Test product + 5-FU/LV Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV |
| Sequence TR: Test Product followed by Reference Product | Experimental | Drug: Irinotecan liposome injection, Drug: Folinic Acid, Drug: 5-FluorouracilCycle 1 (Crossover Phase) Day 1: One dose Onivyde Test product + 5-FU/LV. Cycle 1 (Crossover Phase) Day 15: One dose Onivyde® Reference product + 5-FU/LV. Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan liposome injectionAlso: Onivyde® Reference productOnivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase) | Drug | Sequence RT: Reference Product followed by Test Product |
| Irinotecan liposome injectionAlso: Onivyde Test productOnivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase) | Drug | Sequence RT: Reference Product followed by Test Product |
| Irinotecan liposome injectionAlso: Onivyde Test productOnivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase) | Drug | Sequence TR: Test Product followed by Reference Product |
| Irinotecan liposome injectionAlso: Onivyde® Reference productOnivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase) | Drug | Sequence TR: Test Product followed by Reference Product |
| Folinic AcidAlso: Leucovorin (LV)LV 400 mg/m2 intravenously over 30 minutes, on Day 1 and Day 15 of every 28-day cycle | Drug | Sequence RT: Reference Product followed by Test Product, Sequence TR: Test Product followed by Reference Product |
| 5-FluorouracilAlso: 5-FU5-FU 2,400 mg/m2 intravenously over 46 hours, on Day 1 and Day 15 every 28-day cycle | Drug | Sequence RT: Reference Product followed by Test Product, Sequence TR: Test Product followed by Reference Product |
Primary outcome
Maximum (peak) plasma drug concentration (Cmax) of encapsulated irinotecan for Test relative to and Reference product
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Area under the plasma concentration-time curve from time 0 to time t (AUC(0-t) of encapsulated irinotecan for Test relative to Reference product
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞) of encapsulated irinotecan for Test relative to Reference product
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
10 secondary outcomes
Maximum (peak) plasma drug concentration (Cmax) of total irinotecan for Test relative to Reference product
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Area under the plasma concentration-time curve from time 0 to time t (AUC(0-t)) of total irinotecan for Test relative to Reference product
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞)) of total irinotecan for Test relative to Reference product
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Time to maximum plasma concentration (Tmax) of encapsulated and total irinotecan over 15-days for each Test and Reference products
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Apparent clearance of drug from plasma (CL) of encapsulated and total irinotecan for Test and Reference products
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Apparent volume of distribution (VZ) of encapsulated and total irinotecan for Test and Reference products
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Terminal half-life (t1/2) of encapsulated and total irinotecan for Test and Reference products
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Apparent terminal elimination rate constant (λZ) of encapsulated and total irinotecan for Test and Reference products
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Percentage of participants with treatment-emergent adverse events (TEAEs) treatment-related leading to discontinuations, or to death
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Percentage of participants with clinically significant abnormal values
Time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Irinotecan liposome injection, Folinic Acid and 5-Fluorouracil in people with Metastatic Pancreatic Adenocarcinoma, run by Ipsen at 36 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Spain, Italy, France, Germany, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum (peak) plasma drug concentration (Cmax) of encapsulated irinotecan for Test relative to and Reference product (time frame: Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.