Second Line Treatment With Nal-IRI and S1 in Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the optimal second line treatment strategy in patients with metastatic pancreatic cancer who underwent a therapy with gemcitabine.

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

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Isala; Maastricht University Medical Center; Medical University of Vienna; Odense University Hospital; Odense University Hospital, Denmark; UMC Utrecht; University Hospital Verona, Italy; Vall de Hebron, Barcelona, Spain
• Treatments: Irinotecan; Leucovorin

Criteria

Inclusion Criteria:

Subjects must satisfy all of the following inclusion criteria to be enrolled in the study.

1. Able to understand and provide written informed consent

2. ≥ 18 years of age

3. Histologically or cytologically confirmed adenocarcinoma of pancreas

4. Documented metastatic disease, according to RECIST 1.1.

5. Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine based treatment

6. Adequate hepatic, renal and hematological function

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Serum total bilirubin ≥1.5 x ULN (biliary drainage is allowed for biliary obstruction)

2. Severe renal impairment (CLcr ≤ 30 ml/min)

3. Inadequate bone marrow reserves as evidenced by:

1. ANC ≤ 1,5 x 10 9 /L; or

2. Platelet count ≤ 100 x 10 9 /L;

4. WHO/PS 0-1

5. Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment

6. Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1

7. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months

8. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings

9. Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's health

10. Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors

11. Known hypersensitivity to any of the components of liposomal irinotecan (Nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.

12. Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)

13. Previous treatment with fluoropyrimidine therapy

14. Known dihydropyrimidine dehydrogenase (DPD) deficiency

15. Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of liposomal irinotecan (Nal-IRI).

Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine.