BridgeMD
A randomized phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy
EU CTIS ID: 2023-509463-24-01
What this study is testing
To determine the progression free survival (PFS) benefit of nal-IRI combined with S-1, compared with nal-IRI combined with 5-FU/LV, in subjects pre-treated with gemcitabine based chemotherapy for metastatic pancreatic ductal adenocarcinoma, or progression within 6 months of adjuvant gemcitabine treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able to understand and provide written informed consent
- ≥ 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of pancreas
- Documented metastatic disease, according to RECIST 1.1.
- Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine based treatment
- Adequate hepatic (serum bilirubin total between 0-17 μmol/L, AST between 0-40 U/L, ALT between 0-34 U/L, renal (creatinine between 65-95 μmol/L) and hematological (hemoglobin between 7.5-10 mmol/L, platelets between 150-400 10E9/L, leukocytes between 4.0-10.5 10E9/L) function
You likely can't join if
- Serum total bilirubin ≥1.5 x ULN (biliary drainage is allowed for biliary obstruction)
- Current use or any use in last two weeks of strong CYP2A6- enzyme inhibitors, 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)
- Previous treatment with fluoropyrimidine therapy
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
See the full eligibility criteria
- Able to understand and provide written informed consent
- ≥ 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of pancreas
- Documented metastatic disease, according to RECIST 1.1.
- Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine based treatment
- Adequate hepatic (serum bilirubin total between 0-17 μmol/L, AST between 0-40 U/L, ALT between 0-34 U/L, renal (creatinine between 65-95 μmol/L) and hematological (hemoglobin between 7.5-10 mmol/L, platelets between 150-400 10E9/L, leukocytes between 4.0-10.5 10E9/L) function
- Serum total bilirubin ≥1.5 x ULN (biliary drainage is allowed for biliary obstruction)
- Current use or any use in last two weeks of strong CYP2A6- enzyme inhibitors, 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)
- Previous treatment with 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).
- or male patients: unwilling to use contraception during treatment and 4 months following last dose of Nal-IRI and 6 months after S-1
- Contraception required for 6 months following the last dose of S-1
- Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine.
- Severe renal impairment (CLcr ≤ 30 ml/min)
- Inadequate bone marrow reserves as evidenced by: a. ANC ≤ 1,5 x 10 9 /L; or b. Platelet count ≤ 100 x 10 9 /L;
- WHO/PS 2 or higher
- Any clinically significant disorder impacting the risk-benefit balance negatively per physician’s judgment
- Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.