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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    134
  • sponsor
    Belgian Group of Digestive Oncology
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Updated on 4 October 2022
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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

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)

Details
Condition Metastatic Pancreatic Ductal Adenocarcinoma
Treatment Oxaliplatin, Leucovorin, 5 FU, Nanoliposomal Irinotecan
Clinical Study IdentifierNCT05472259
SponsorBelgian Group of Digestive Oncology
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
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