Pancreatic Cancer MetastaticNALLONGNCT06155136
RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan
An observational study of Pancreatic Cancer Metastatic, run by Servier Affaires Médicales at 1 site in Germany.
Trial summary
The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Metastatic
- How many people
- 163 participants
- Where
- 1 siteGermany
- Study dates
- 6 Oct 2023to 30 Sep 2024
- 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: Adult patients still alive one year after the initiation of NAliri
Who may be able to join
- Age ≥ 18 years (≥ 19 years in South Korea)
- Cytologically confirmed mPDAC at initiation of the nal-IRI treatment
- All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
- Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
- At least one cycle of nal-IRI-containing regimen should have been administered
- A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen)
- Availability of data related to survival outcomes in the patient medical record
- Patients deceased or not at the time of enrollment will be eligible for inclusion in the study
Who cannot join
- No documentation of systemic therapy outcomes or prior treatments in patient medical records
- Patients with second concomitant metastatic malignancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der Universität München, - Anstalt des öffentlichen Rechts -
Munich, 81377
About this study
Official title: Real-world Evidence on Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)
The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI
Read the detailed description
The objectives on patients still alive one year after the first cycle of nal-IRI :
- Characterize mPDAC patient population according to their demographics
- Identify PDAC treatment by line of treatment from diagnosis to last treatment
- Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival
- Conditions
- Pancreatic Cancer Metastatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease characteristic according to age
Tumor stage (localized/locally advanced/metastatic)
Measured: Through study completion (approximatively 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start6 Oct 2023
- Primary completion30 Mar 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Affaires Médicales
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155136
- Sponsor's protocol ID
- DIM-95013-001-INT
- Acronym
- NALLONG
- Status last verified
- Apr 2024
- First submitted
- 24 Nov 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evidence on Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)
- ClinicalTrials.gov ID
- NCT06155136
- Acronym / sponsor ID
- NALLONG / DIM-95013-001-INT
- Conditions
- Pancreatic Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Servier Affaires MédicalesIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 4 Dec 2023 (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 objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI
Detailed description
The objectives on patients still alive one year after the first cycle of nal-IRI :
- Characterize mPDAC patient population according to their demographics
- Identify PDAC treatment by line of treatment from diagnosis to last treatment
- Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients still alive one year after the initiation of NAliri
Key inclusion criteria (8 listed)
- Age ≥ 18 years (≥ 19 years in South Korea)
- Cytologically confirmed mPDAC at initiation of the nal-IRI treatment
- All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
- Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
- At least one cycle of nal-IRI-containing regimen should have been administered
Key exclusion criteria (2 listed)
- No documentation of systemic therapy outcomes or prior treatments in patient medical records
- Patients with second concomitant metastatic malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease characteristic according to age
Time frame: Through study completion (approximatively 5 months)
Tumor stage (localized/locally advanced/metastatic)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
Related trials for Pancreatic Cancer Metastatic
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic Cancer Metastatic, run by Servier Affaires Médicales at 1 site in Germany.
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 8 inclusion and 2 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 22 Apr 2024. 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 Germany. 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?
Disease characteristic according to age (time frame: Through study completion (approximatively 5 months)). 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 22 Apr 2024.