At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 151 enrolled
Drug / intervention
Irinotecan Liposomal Injection [Onivyde]drug
Likely dose
Irinotecan Liposomal Injection [Onivyde] 4.3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Second-line Therapy With Nal-IRI After Failure Gemcitabine/Nab-paclitaxel in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy
In Brief
A Phase 3 clinical trial evaluating Irinotecan Liposomal Injection [Onivyde] for Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer. Completed, enrolled 151 participants across 35 sites.
Detailed Summary
Second-line therapy with Nal-IRI after failure gemcitabine/nab-paclitaxel in advanced pancreatic cancer - predictive role of 1st-line therapy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
CollaboratorsCrolll Gmbh, Servier Deutschland GmbH
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartMar 2018
Primary CompletionMay 2022
TodayJul 2026
First PostedMar 16, 2018
Enrollment StartMar 31, 2018
Primary CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8.3 years ago
Interventions
Irinotecan Liposomal Injection [Onivyde]drug
Cancer treatment for PDAC: * Nal-IRI (4.3 mg/ml) 70 mg/m2 as 1.5 hour infusion * 5-FU 2400 mg/m2 as 46 hour infusion * Folinic acid 400 mg/m2 as 0.5 hour infusion * all on D1 of each cycle; Cycle q2w ± 5 days Treatment until progressive disease or intolerable toxicity or withdrawal of consent.