Phase II study of treatment with liposomal and S1 irinotecan versus liposomal and 5-fluorouracil irinotecan in patients with metastatic pancreatic cancer who did not achieve results with gemcitabine first-line chemotherapy

Phase 1

• Conditions: pancreatic cancer; MedDRA version: 21.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004675-31-IT
• Lead Sponsor: ACADEMIC MEDICAL CENTRE AMSTERDAM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

= 18 years of age
Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
Documented metastatic disease
Previously treated with gemcitabine or gemcitabine containing therapy,
or progression within 6 months of adjuvant gemcitabine treatment
Adequate hepatic, renal and hematological function
Caucasian
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

KPS < 70
Any clinically significant gastrointestinal disorder, including hepaticdisorders, bleeding, inflammation, occlusion, or diarrhea > grade 2
Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically
significant abnormal findings
Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's
health
Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
Known hypersensitivity to any of the components of liposomal irinotecan (nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
History of severe and unexpected reactions to fluoropyrimidine therapy
Known dihydropyrimidine dehydrogenase (DPD) deficiency
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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose<br>(MTD) of nal-IRI when co-administered with fixed dose S1 in patients<br>with metastatic pancreatic cancer.<br>Phase II part: Efficacy between the treatment arms in terms of<br>progression free survival.;Secondary Objective: Overall survival<br>Response rate according to RECIST 1.1<br>Adverse events according to NCI CTC version 4.0<br>Quality of life;Primary end point(s): Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose (MTD) of nal-IRI when co-administered with fixed dose S1 in patients with metastatic pancreatic cancer.<br>Phase II part: Efficacy between the treatment arms in terms of progression free survival.;Timepoint(s) of evaluation of this end point: Evaluation with CTscan/ MRI will take place every 2 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of life; Response rate according to RECIST 1.1; Adverse events according to NCI CTC version 4.0; Overall survival;Timepoint(s) of evaluation of this end point: Quality of life will be evaluated every 2 months; Evaluation with CTscan/ MRI will take place every 2 months; Adverse events will be evaluated every 2 weeks; Evaluation with CTscan/ MRI will take place every 2 months