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

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03468335
Phase
PHASE3
Status
Completed

Conditions

  • Locally Advanced Pancreatic Cancer
  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Mar 31, 2018
Status verified
Apr 2025
Primary completion
May 31, 2022
Completion
May 31, 2022

Study Design

Enrollment
151 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm
    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.

Primary Outcome Measure

Time to Treatment Failure of second-line treatment (TTF2) [ Time Frame: up to 6 month ]

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