Metastatic Pancreatic Ductal AdenocarcinomaNALIRINCT05095064
Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan
An observational study of Metastatic Pancreatic Ductal Adenocarcinoma, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The aim of this retrospective study is to confirm the efficacy and safety results obtained in the NAPOLI-1-study, when Onivyde® in combination with 5-FU/LV is used in real-life practice in Belgium. The data needed to do so will be obtained using information that is routinely collected as part of patient's medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Onivyde® + 5-FULV
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Sep 2021to 1 Mar 2022
- Phase
- Observational
- 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
Study population: Metastatic pancreatic ductal adenocarcinoma
Who may be able to join
- Patient has diagnosis of pancreatic adenocarcinoma with documented metastatic disease.
- Patient progressed after gemcitabine-based therapy.
- Patient received at least one treatment cycle with Onivyde® + 5-FU/LV 5FU in the context of post-gemcitabine based therapy of mPDAC.
Who cannot join
- Patient has not received at least one treatment cycle with Onivyde® + 5-FU/LV.
- Previous irinotecan-based therapy in metastatic setting.
- Patientstarted the treatment with Onivyde® + 5-FU/LV after 01/04/2021
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study on the Efficacy and Tolerability of Liposomal irinotecanN (MM398, PEP02, Onivyde) for the Treatment of Pancreatic Adenocarcinoma.
The aim of this retrospective study is to confirm the efficacy and safety results obtained in the NAPOLI-1-study, when Onivyde® in combination with 5-FU/LV is used in real-life practice in Belgium. The data needed to do so will be obtained using information that is routinely collected as part of patient's medical care.
Read the detailed description
Patients with pancreatic cancer have a poor prognosis with a 5-years survival of only 1-2%. This arises from the fact that it is typically diagnosed late, when curative resection is impossible. These patients are thus restricted to chemotherapy, with gemcitabine-based therapies being the standard of care for patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC). However, even after second or subsequent lines of therapy, disease progression is inevitable. Therefore, the need for new treatment options is high. Recently, the advantage of using nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV) over the use of 5-FU/LV alone was demonstrated in a phase-3 randomized clinical trial (NAPOLI-1 trial). As this study showed significant improvement on overall survival, progression-free survival, time to treatment failure, overall response rate and tumor marker CA19-9 response, on October 14 2016 this therapy was approved by the EMA to be used for patients with mPDAC previously treated with gemcitabine-based therapy.
While randomized clinical trials, like the NAPOLI-1 trial, are considered the reference standard for comparing the efficacy and safety of treatments, these studies do not always reflect the everyday clinical practice. Therefore, the aim of this study is to evaluate the efficacy and safety of Onivyde® in real-life practice in Belgium. This information would be very valuable to determine the value of the drug and improve the knowledge of the actual use of Onivyde® after marketing authorization.
- Being tested
- Onivyde® + 5-FULV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onivyde® + 5-FULVDrug
Also called Nanoliposomal irinotecan
Nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV)
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall survival (OS) from start of treatment with Onivyde® + 5-FU/LV
All this info is retrospectively obtained from the patients medical fistory. Data analysis is forseen to be finished 03/2022.
Measured: 03/2022
Secondary outcomes (5)
Survival rate at 2, 4, 6, 8, 10 months from the start of treatment with Onivyde® + 5-FU/LV
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Measured: 03/2022
Progression-free survival (PFS) from the start of Onivyde® + 5-FU/LV treatment
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Measured: 03/2022
Disease control rate of patients from the start of treatment with Onivyde® + 5-FU/LV
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Measured: 03/2022
Change in baseline performance status of the patient after Onivyde® + 5-FU/LV treatment
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Measured: 03/2022
The OS from the date of diagnosis of metastatic disease
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Measured: 03/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start27 Sep 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, AZ Nikolaas, General Hospital Groeninge, University Hospital St Luc, Brussels, ASZ Aalst, Erasme University Hospital, Centre Hospitalier Universitaire de Liege, OLVZ Ziekenhuis Aalst
- Responsible party
- Sponsor
- Investigators
- Marc Peeters, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095064
- Sponsor's protocol ID
- EDGE 001385
- Acronym
- NALIRI
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verbruggen L, Verheggen L, Vanhoutte G, Loly C, Lybaert W, Borbath I, Vergauwe P, Hendrickx K, Debeuckelaere C, de Haar-Holleman A, Van Laethem JL, Peeters M. A real-world analysis on the efficacy and tolerability of liposomal irinotecan plus 5-fluorouracil and folinic acid in metastatic pancreatic ductal adenocarcinoma in Belgium. Ther Adv Med Oncol. 2023 Aug 18;15:17588359231181500. doi: 10.1177/17588359231181500. eCollection 2023.
PubMed 37600936
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on the Efficacy and Tolerability of Liposomal irinotecanN (MM398, PEP02, Onivyde) for the Treatment of Pancreatic Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT05095064
- Acronym / sponsor ID
- NALIRI / EDGE 001385
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, AZ Nikolaas, General Hospital Groeninge, University Hospital St Luc, Brussels, ASZ Aalst, Erasme University Hospital, Centre Hospitalier Universitaire de Liege, OLVZ Ziekenhuis Aalst
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 27 Oct 2021 (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 retrospective study is to confirm the efficacy and safety results obtained in the NAPOLI-1-study, when Onivyde® in combination with 5-FU/LV is used in real-life practice in Belgium. The data needed to do so will be obtained using information that is routinely collected as part of patient's medical care.
Detailed description
Patients with pancreatic cancer have a poor prognosis with a 5-years survival of only 1-2%. This arises from the fact that it is typically diagnosed late, when curative resection is impossible. These patients are thus restricted to chemotherapy, with gemcitabine-based therapies being the standard of care for patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC). However, even after second or subsequent lines of therapy, disease progression is inevitable. Therefore, the need for new treatment options is high. Recently, the advantage of using nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV) over the use of 5-FU/LV alone was demonstrated in a phase-3 randomized clinical trial (NAPOLI-1 trial). As this study showed significant improvement on overall survival, progression-free survival, time to treatment failure, overall response rate and tumor marker CA19-9 response, on October 14 2016 this therapy was approved by the EMA to be used for patients with mPDAC previously treated with gemcitabine-based therapy.
While randomized clinical trials, like the NAPOLI-1 trial, are considered the reference standard for comparing the efficacy and safety of treatments, these studies do not always reflect the everyday clinical practice. Therefore, the aim of this study is to evaluate the efficacy and safety of Onivyde® in real-life practice in Belgium. This information would be very valuable to determine the value of the drug and improve the knowledge of the actual use of Onivyde® after marketing authorization.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic pancreatic ductal adenocarcinoma
Key inclusion criteria (3 listed)
- Patient has diagnosis of pancreatic adenocarcinoma with documented metastatic disease.
- Patient progressed after gemcitabine-based therapy.
- Patient received at least one treatment cycle with Onivyde® + 5-FU/LV 5FU in the context of post-gemcitabine based therapy of mPDAC.
Key exclusion criteria (3 listed)
- Patient has not received at least one treatment cycle with Onivyde® + 5-FU/LV.
- Previous irinotecan-based therapy in metastatic setting.
- Patientstarted the treatment with Onivyde® + 5-FU/LV after 01/04/2021
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 |
|---|---|---|
| Onivyde® + 5-FULVAlso: Nanoliposomal irinotecanNanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV) | Drug | – |
Primary outcome
The overall survival (OS) from start of treatment with Onivyde® + 5-FU/LV
Time frame: 03/2022
All this info is retrospectively obtained from the patients medical fistory. Data analysis is forseen to be finished 03/2022.
5 secondary outcomes
Survival rate at 2, 4, 6, 8, 10 months from the start of treatment with Onivyde® + 5-FU/LV
Time frame: 03/2022
Progression-free survival (PFS) from the start of Onivyde® + 5-FU/LV treatment
Time frame: 03/2022
Disease control rate of patients from the start of treatment with Onivyde® + 5-FU/LV
Time frame: 03/2022
Change in baseline performance status of the patient after Onivyde® + 5-FU/LV treatment
Time frame: 03/2022
The OS from the date of diagnosis of metastatic disease
Time frame: 03/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Derived from this study: PubMed 37600936Verbruggen L, Verheggen L, Vanhoutte G, Loly C, Lybaert W, Borbath I, Vergauwe P, Hendrickx K, Debeuckelaere C, de Haar-Holleman A, Van Laethem JL, Peeters M. A real-world analysis on the efficacy and tolerability of liposomal irinotecan plus 5-fluorouracil and folinic acid in metastatic pancreatic ductal adenocarcinoma in Belgium. Ther Adv Med Oncol. 2023 Aug 18;15:17588359231181500. doi: 10.1177/17588359231181500. eCollection 2023.
- 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.
Marc Peeters principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Pancreatic Ductal Adenocarcinoma, run by University Hospital, Antwerp at 1 site in Belgium.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
Are results available for this study?
Results are not available in the source record.
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?
The overall survival (OS) from start of treatment with Onivyde® + 5-FU/LV (time frame: 03/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095064, which also lists 1 linked publication.
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 15 Feb 2022.