Metastatic Pancreatic Ductal AdenocarcinomaPhase 2NALPACNCT05472259
A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
A Phase 2 study testing Nanoliposomal irinotecan, 5 FU and Leucovorin in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Belgian Group of Digestive Oncology at 13 sites in Belgium.
Trial summary
A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy 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?
- Nanoliposomal irinotecan, 5 FU and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 13 sitesBelgium
- Study dates
- 25 May 2022to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically proven metastatic adenocarcinoma of the pancreas
- Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy
- Signed written informed consent
- Age ≥ 18
- ECOG PS 0/1 at study entry
- Measurable disease
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- Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109/L, platelets ≥ 100x109/L, hemoglobin ≥ 9g/dl)
- INR/PTT ≤ 1.5x ULN
- Life expectancy of at least 12 weeks
- Effective contraception for both male and female patients if the risk of conception exists during treatment and for one month after the last administration
- Peripheral Neuropathy < grade 2
Who cannot join
- Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
- History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
- Known hypersensitivity to any of the components, including excipients, of study treatments
- Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type
- Pregnancy or breast feeding
- Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
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- Unstable angina, congestive heart failure ≥NYHA class II
- Uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg)
- HIV infection
- Complete DPD deficiency
- Liver failure, cirrhosis Child Pugh B or C
- Active chronic hepatitis B or C with a need for antiviral treatment
- Brain metastasis
- Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment
- History of organ allograft
- Ongoing uncontrolled, serious infection
- Renal failure requiring dialysis
- Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Belgium13 sites, 13 recruiting
- Recruiting
UZ Antwerpen
Antwerp, Antwerp, 2650
Sanne Wouters
Timon Vandamme, Prof
- Recruiting
AZ Imelda
Bonheiden
Doreen Iwens
Pieter-Jan Cuyle, Dr.
- Not yet recruiting
AZ St-Lucas
Bruges, West-Vlaanderen
Tania Maerten
Liesbeth Holvoet, Dr
- Recruiting
ULB Erasme
Brussels, Brussels Capital, 1070
Axelle Ghilain
Jean-Luc Van Laethem, Dr
- Recruiting
Cliniques Universitaires Saint-Luc UCL
Brussels, Brussels Capital, 1200
Tuan Le
Ivan Borbath, Prof
- Recruiting
Grand Hopital de Charleroi
Charleroi
Matthias Papier
Javier Carrasco, Dr.
- Recruiting
AZ Maria Middelares
Ghent
Margaux Vansteelant
Els Monsaert, Dr.
- Recruiting
University Hospital Ghent
Ghent
Tine Derre
Karen Geboes, Prof.
- Recruiting
Pôle Hospitalier Jolimont (HELORA)
Haine-Saint-Paul, 7100
Isabelle Buelens, 064/234662, Isabelle.Buelens@helora.be
- Recruiting
CHC MontLégia
Liège, Liège, 4000
Jocelyne Gilson
Ghislain Houbiers, Dr
- Recruiting
CHU Ambroise Paré
Mons
Mariane Blockmans
Marie Diaz, Dr.
- Recruiting
CHR Namur
Namur
Christine Leon
Yeter Gokburun, Dr.
- Recruiting
AZ Turnhout
Turnhout, 2300
Nel Bovin, 0032 14406912, nel.bovin@azturnhout.be
About this study
Official title: A Non-comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abraxane or Gemcitabine Monotherapy
A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy
Read the detailed description
Based on the results of previous studies, the sponsor aims to assess efficacy and safety of this triplet (irinotecan, 5FU/LV and oxaliplatin) in second-line treatment in fit patients (ECOG 0-1) metastatic PDAC.
The primary objective is to assess the efficacy of NALIRINOX (= investigational arm) and NALIRI (= standard care arm) in terms of Progression-Free Survival Rate (PFSR).
As secondary objectives, the following will be evaluated in both arms:
- Safety/toxicity and tolerability profile according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.
- Progression free survival (PFS)
- Overall response rate and duration of response as assessed by imaging (RECIST 1.1) and tumor markers
- Overall survival (OS)
- Being tested
- Nanoliposomal irinotecan, 5 FU, Leucovorin, Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoliposomal irinotecanDrug
Also called Onyvide
In the control arm (Naliri) a dose of 70mg/m² is administered in combination with 5FU and leucovorin In the investigational arm (Nalirinox) a dose of 50mg/m² is administered in combination with 5FU, leucovorin and oxaliplatin
5 FUDrug
Also called Fluorouracil
In the control arm (Naliri) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan and leucovorin In the investigational arm (Nalirinox) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan, leucovorin and oxaliplatin
LeucovorinDrug
Also called Folinate, Elvorine
In the control arm (Naliri) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan and 5FU In the investigational arm (Nalirinox) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and oxaliplatin
OxaliplatinDrug
Only administered in the investigational arm (Nalirinox): a dose of 60 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and Leucovorin
| Study group | Role | What they receive |
|---|---|---|
| Arm A NALIRI | Active comparator | Cycle length: 14 days
Day 1:
* Leucovorin: 400 mg/m² IV - Dilute in 250 mL DSW and administer over two hours
* Liposomal irinotecan (FBE): 70 mg/m² IV* - Dilute in 500 mL DSW and administer over 90 min
* 5 FU: 2400 mg/m² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg/mL) or the total dose diluted in 100 to 150 mL NS.
* Patients who are known to be homozygous for UGT1A1*28 should start treatment with 50 mg/m2 ONIVYDE. If they do not encounter drug related toxicities during the first cycle of therapy (started at a reduced dose of 50 mg/m2), they may have the dose of ONIVYDE increased to a dose of 70 mg/m2 in subsequent cycles based on individual patient tolerance. Receives: Drug: Nanoliposomal irinotecan; Drug: 5 FU; Drug: Leucovorin |
| Arm B NALIRINOX | Experimental | Cycle length: 14 days
Day 1:
* Oxaliplatin 60 mg IV - Dilute in 500 mL D5W and administer over two hours (prior to leucovorin). Shorter oxaliplatin administration schedules (eg. 1mg/m2 per minute) appear to be safe.
* Leucovorin: 400 mg/m² IV - Dilute in 250 mL DSW and administer over two hours (after oxaliplatin)
* Nanoliposomal irinotecan (FBE): 50 mg/m² IV - Dilute in 500 mL D5W and administer over 90 min
* 5 FU: 2400 mg/m² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg/mL) or the total dose diluted in 100 to 150 mL NS. Receives: Drug: Nanoliposomal irinotecan; Drug: 5 FU; Drug: Leucovorin; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of NALIRINOX and NALIRI through Progression-Free Survival at D85
NALIRINOX is the investigational arm and NALIRI is the standard care arm. The efficacy will be assessed in terms of the Progression-Free Survival Rate (PFSR). This is defined as the proportion of patients alive and free of progression at day 85.
Measured: at day 85 from randomization
Secondary outcomes (12)
Safety/toxicity and tolerability profil: Severety of adverse events
Adverse events and Serious Adverse events will be assessed during the study treatment and until 14 days later. Severety will be graded according to the NCI-CTCAE version 5.0 and relationship to the study medication will be defined.
Measured: until 14 days after End of Treatment
Safety/toxicity and tolerability profil: Laboratory assessments
Standard laboratory safety assessments: They are mandatory prior to each administration of study medication and at the 15 days follow-up visit.
Clinically significant vs not clinically significant.
Measured: until 14 days after End of Treatment
Safety/toxicity and tolerability profil: ECOG
WHO ECOG performance status (PS) will be defined prior to each administration of study medication and at the 15 days follow-up visit following the ECOG Performance Status Scale.
Measured: until 14 days after End of Treatment
Safety/toxicity and tolerability profil: review of body systems
A full review of body systems will be performed: heart rate, blood pressure, respiratory rate, body temperature, height, weight and ECG (screening visit only, unless clinically indicated).
Clinically significant versus not clinically significant
Measured: until 14 days after End of Treatment
Progression Free Survival and sensitivity analysis: Effect of Center on prognostic factors
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
- Investigational Center
Measured: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment.
Progression Free Survival and sensitivity analysis: Effect of tumor location on prognostic factors
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
- Location of tumor (head of the pancreas versus other location)
Measured: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment
Progression Free Survival and sensitivity analysis: Effect of previous chemotherapy on prognostic factors
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
- Previous chemotherapy: gemcitabine alone vs gem-abx
Measured: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment
Progression Free Survival and sensitivity analysis: effect of ECOG on prognostic factors
The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
- WHO ECOG performance status (0 versus 1)
Measured: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment
Objective tumor response: Rate of complete response and partial response
Tumor (response) evaluation will be performed according to RECIST criteria v. 1.1 (CT scan thorax, abdomen and pelvis or MRI abdomen and pelvis + CT chest) based upon the investigator's assessment. Overall response is defined as a best response of either CR or PR (CR+PR).
Measured: performed within 28 days before start therapy, 3 times every 6 weeks and afterwards every 8 weeks
Duration of overall survival
For patients who are still alive at the time of study analysis or who are lost to follow up, survival will be censored at the last recorded date that the patient is known to be alive or at the date of data cut-off, whatever occurs earlier.
Measured: Time from Day 1 of therapy to death until maximum 5 years after End of Treatment
Duration of disease control
Disease control is defined as a best response of either CR, PR, or SD (CR+PR+SD).
Measured: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment
Duration of response
The duration of response will be censored on the date of last known tumor assessment for not progressed patients lost to follow up or deceased prior to the next planned tumor assessment (within 60 days). Not evaluable patients at one time point assessment will be censored at the date of last known assessment.
Measured: Time from measurement criteria are first met for CR/PR to either the first time disease progression is documented or death (for not progressed patients who deceased within 60 days from last tumor assessment) until maximum 5 years after EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start25 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belgian Group of Digestive Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital St Luc, Brussels
- Responsible party
- Sponsor
- Investigators
- Ivan Borbath, Principal investigator, University hospital St-luc, Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472259
- Sponsor's protocol ID
- NALPAC
- Acronym
- NALPAC
- Status last verified
- Feb 2024
- First submitted
- 9 Dec 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abraxane or Gemcitabine Monotherapy
- ClinicalTrials.gov ID
- NCT05472259
- Acronym / sponsor ID
- NALPAC / NALPAC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Belgian Group of Digestive OncologyUniversity, hospital or other
- Collaborators
- University Hospital St Luc, Brussels
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jul 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.
A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy
Detailed description
Based on the results of previous studies, the sponsor aims to assess efficacy and safety of this triplet (irinotecan, 5FU/LV and oxaliplatin) in second-line treatment in fit patients (ECOG 0-1) metastatic PDAC.
The primary objective is to assess the efficacy of NALIRINOX (= investigational arm) and NALIRI (= standard care arm) in terms of Progression-Free Survival Rate (PFSR).
As secondary objectives, the following will be evaluated in both arms:
- Safety/toxicity and tolerability profile according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.
- Progression free survival (PFS)
- Overall response rate and duration of response as assessed by imaging (RECIST 1.1) and tumor markers
- Overall survival (OS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A NALIRI | Active comparator | Drug: Nanoliposomal irinotecan, Drug: 5 FU, Drug: LeucovorinCycle length: 14 days Day 1: * Leucovorin: 400 mg/m² IV - Dilute in 250 mL DSW and administer over two hours * Liposomal irinotecan (FBE): 70 mg/m² IV* - Dilute in 500 mL DSW and administer over 90 min * 5 FU: 2400 mg/m² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg/mL) or the total dose diluted in 100 to 150 mL NS. * Patients who are known to be homozygous for UGT1A1*28 should start treatment with 50 mg/m2 ONIVYDE. If they do not encounter drug related toxicities during the first cycle of therapy (started at a reduced dose of 50 mg/m2), they may have the dose of ONIVYDE increased to a dose of 70 mg/m2 in subsequent cycles based on individual patient tolerance. |
| Arm B NALIRINOX | Experimental | Drug: Nanoliposomal irinotecan, Drug: 5 FU, Drug: Leucovorin, Drug: OxaliplatinCycle length: 14 days Day 1: * Oxaliplatin 60 mg IV - Dilute in 500 mL D5W and administer over two hours (prior to leucovorin). Shorter oxaliplatin administration schedules (eg. 1mg/m2 per minute) appear to be safe. * Leucovorin: 400 mg/m² IV - Dilute in 250 mL DSW and administer over two hours (after oxaliplatin) * Nanoliposomal irinotecan (FBE): 50 mg/m² IV - Dilute in 500 mL D5W and administer over 90 min * 5 FU: 2400 mg/m² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg/mL) or the total dose diluted in 100 to 150 mL NS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven metastatic adenocarcinoma of the pancreas
- Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy
- Signed written informed consent
- Age ≥ 18
- ECOG PS 0/1 at study entry
Key exclusion criteria (18 listed)
- Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
- History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
- Known hypersensitivity to any of the components, including excipients, of study treatments
- Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type
- Pregnancy or breast feeding
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 |
|---|---|---|
| Nanoliposomal irinotecanAlso: OnyvideIn the control arm (Naliri) a dose of 70mg/m² is administered in combination with 5FU and leucovorin In the investigational arm (Nalirinox) a dose of 50mg/m² is administered in combination with 5FU, leucovorin and oxaliplatin | Drug | Arm A NALIRI, Arm B NALIRINOX |
| 5 FUAlso: FluorouracilIn the control arm (Naliri) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan and leucovorin In the investigational arm (Nalirinox) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan, leucovorin and oxaliplatin | Drug | Arm A NALIRI, Arm B NALIRINOX |
| LeucovorinAlso: Folinate, ElvorineIn the control arm (Naliri) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan and 5FU In the investigational arm (Nalirinox) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and oxaliplatin | Drug | Arm A NALIRI, Arm B NALIRINOX |
| OxaliplatinOnly administered in the investigational arm (Nalirinox): a dose of 60 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and Leucovorin | Drug | Arm B NALIRINOX |
Primary outcome
Efficacy of NALIRINOX and NALIRI through Progression-Free Survival at D85
Time frame: at day 85 from randomization
NALIRINOX is the investigational arm and NALIRI is the standard care arm. The efficacy will be assessed in terms of the Progression-Free Survival Rate (PFSR). This is defined as the proportion of patients alive and free of progression at day 85.
12 secondary outcomes
Safety/toxicity and tolerability profil: Severety of adverse events
Time frame: until 14 days after End of Treatment
Safety/toxicity and tolerability profil: Laboratory assessments
Time frame: until 14 days after End of Treatment
Safety/toxicity and tolerability profil: ECOG
Time frame: until 14 days after End of Treatment
Safety/toxicity and tolerability profil: review of body systems
Time frame: until 14 days after End of Treatment
Progression Free Survival and sensitivity analysis: Effect of Center on prognostic factors
Time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment.
Progression Free Survival and sensitivity analysis: Effect of tumor location on prognostic factors
Time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment
Progression Free Survival and sensitivity analysis: Effect of previous chemotherapy on prognostic factors
Time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment
Progression Free Survival and sensitivity analysis: effect of ECOG on prognostic factors
Time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment
Objective tumor response: Rate of complete response and partial response
Time frame: performed within 28 days before start therapy, 3 times every 6 weeks and afterwards every 8 weeks
Duration of overall survival
Time frame: Time from Day 1 of therapy to death until maximum 5 years after End of Treatment
Duration of disease control
Time frame: From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment
Duration of response
Time frame: Time from measurement criteria are first met for CR/PR to either the first time disease progression is documented or death (for not progressed patients who deceased within 60 days from last tumor assessment) until maximum 5 years after EOT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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.
Ivan Borbath principal investigator
University hospital St-luc, Brussel
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nanoliposomal irinotecan, 5 FU and Leucovorin in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Belgian Group of Digestive Oncology at 13 sites 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 11 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Dewever (+32 (0) 479 36 63 82, lina.dewever@bgdo.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of NALIRINOX and NALIRI through Progression-Free Survival at D85 (time frame: at day 85 from randomization). 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 6 Feb 2025.