pancreatic cancer
Conditions
Interventions
Trade Name: ONIVYDE
Product Name: onivyde
Product Code: EMA/515476/2016
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Irinotecanhydrochlorid
CAS Number: 97682-44
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Able to understand and provide written informed consent = 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
Exclusion criteria: KPS 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. Phase II part: Efficacy between the treatment arms in terms of progression free survival. ;Secondary Objective: Overall survival Response rate according to RECIST 1.1 Adverse events according to NCI CTC version 4.0 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival Response rate according to RECIST 1.1 Adverse events according to NCI CTC version 4.0 Quality of life ;Timepoint(s) of evaluation of this end point: Evaluation with CTscan/ MRI will take place every 2 months Adverse events will be evaluated every 2 weeks Quality of life will be evaluated every 2 months | — |
Countries
Austria, Denmark, Italy, Netherlands, Spain
Contacts
Public ContactEva van Daalen
Academic Medical Center
Outcome results
None listed