“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.
- Conditions
- METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
- Registration Number
- 2024-516336-97-00
- Lead Sponsor
- Groupe Belge D'Oncologie Digestive
- Brief Summary
Progression-free-survival rate (PFSR) at day 85
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 134
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD). PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD).
- Secondary Outcome Measures
Name Time Method Safety/toxicity and tolerability profile: Adverse events, laboratory safety assessment, physical examination Safety/toxicity and tolerability profile: Adverse events, laboratory safety assessment, physical examination
PFS and sensitivity analysis PFS and sensitivity analysis
Objective tumor response according to RECIST v 1.1 Objective tumor response according to RECIST v 1.1
Overall survival Overall survival
Disease control Disease control
Duration of response Duration of response
Exploratory endpoint: Translational analysis on tumor tissue and blood samples Exploratory endpoint: Translational analysis on tumor tissue and blood samples
Trial Locations
- Locations (12)
AZ Turnhout
🇧🇪Turnhout, Belgium
Antwerp University Hospital
🇧🇪Edegem, Belgium
Az Sint-Lucas
🇧🇪Brugge, Belgium
CHU Helora
🇧🇪La Louviere, Belgium
Grand Hopital De Charleroi
🇧🇪Charleroi, Belgium
Az Maria Middelares Gent
🇧🇪Gent, Belgium
Centre Hospitalier Regional Sambre et Meuse
🇧🇪Namur, Belgium
CHC MontLegia
🇧🇪Liege, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Sint-Lambrechts-Woluwe, Belgium
Scroll for more (2 remaining)AZ Turnhout🇧🇪Turnhout, BelgiumLeen MortierSite contact014406912leen.mortier@azturnhout.be