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 1

• Conditions: Pancreatic ductal adenocarcinoma (PDAC); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003889-39-BE
• Lead Sponsor: Belgian Group of Digestive Oncology (BGDO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-19
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. Histologically proven metastatic adenocarcinoma of the pancreas
2. Progression documented after Gemcitabine-Abraxane or gemcitabine alone
3. Signed written informed consent
4. Age = 18
5. ECOG PS 0/1 at study entry
6. Measurable disease
7. 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)
8. INR/PTT = 1.5x ULN
9. Life expectancy of at least 12 weeks
10. Effective contraception for both male and female patients if the risk of conception exists
11. Peripheral Neuropathy < grade 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

1. Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
2. History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
3. Known hypersensitivity to any of the components of study treatments
4. 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
5. Pregnancy or breast feeding
6. Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
7. Unstable angina, congestive heart failure =NYHA class II
8. Uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg)
9. Complete DPD deficiency
10. HIV infection
11. Liver failure, cirrhosis Child Pugh B or C
12. Active chronic hepatitis B or C with a need for antiviral treatment
13. Brain metastasis
14. Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment
15. History of organ allograft
16. Ongoing uncontrolled, serious infection
17. Renal failure requiring dialysis
18. Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified