A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)

• Status: Recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belgian Group of Digestive Oncology
• Collaborator: University Hospital St Luc, Brussels
• Treatments: Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

• 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