NCT03468335

2nd-line Therapy With Nal-IRI After Gem/Nab-pac in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy

Second-line Therapy With Nal-IRI After Failure Gemcitabine/Nab-paclitaxel in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Second-line therapy with Nal-IRI after failure gemcitabine/nab-paclitaxel in advanced pancreatic cancer - predictive role of 1st-line therapy

Detailed description

Research hypothesis: Patients profit from 2nd-line therapy with Nal-IRI if they also had a benefit from 1st-line treatment. Benefit from treatment (either 1st or 2nd-line) will be defined as a patient specific Time-To-Treatment Failure (TTF) which is in the upper third of the distribution of TTF values of the studied population.

Conditions

• Locally Advanced Pancreatic Cancer
• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan Liposomal Injection [Onivyde]	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.

Timeline

• Start date: 2018-03-31
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2018-03-16
• Last updated: 2025-04-17

Locations

35 sites across 1 country: Germany