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“NALPAC” 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.
EU CTIS ID: 2024-516336-97-00
What this study is testing
Progression-free-survival rate (PFSR) at day 85
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven metastatic adenocarcinoma of the pancreas
- Effective contraception for both male and female patients if the risk of conception exists
- Peripheral Neuropathy < grade 2
- Progression documented after first line treatment with Gemcitabine-Abraxane or gemcitabine alone
- Signed written informed consent
- Age ≥ 18
You likely can't join if
- Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
- 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
See the full eligibility criteria
- Histologically proven metastatic adenocarcinoma of the pancreas
- Effective contraception for both male and female patients if the risk of conception exists
- Peripheral Neuropathy < grade 2
- Progression documented after first line treatment with Gemcitabine-Abraxane or gemcitabine alone
- Signed written informed consent
- Age ≥ 18
- ECOG PS 0/1 at study entry
- Measurable disease
- 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
- Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
- 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 the first dose of treatment, or participating to another clinical study
- The following drugs are noted as interacting with Pegylated liposomal irinotecan (in combination with 5-FU and LV, in patients who have progressed following gemcitabine-based therapy), and are therefore excluded from the study: Live or live-attenuated vaccines in patients immunocompromised by chemotherapy, strong CYP3A4 inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John’s wort. Strong CYP3A4 inhibitors (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole and ketoconazole). Strong CYP3A4 inhibitors should be discontinued at least 1 week prior to starting ONIVYDE pegylated liposomal therapy. Strong UGT1A1 inhibitors (e.g. atazanavir, gemfibrozil, indinavir, regorafenib)
- History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
- Known hypersensitivity to any of the components of study treatments
- Previous malignancy in the last past 3 years except basal cell cancer of the skin, pre-invasive 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
- Unstable angina, congestive heart failure ≥NYHA class II
- Uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg
- HIV infection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.