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

NCT03468335 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2025-04-17

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Crolll Gmbh

    collaborator OTHER

  • Servier Deutschland GmbH

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03468335 on ClinicalTrials.gov