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NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer

NCT04005339 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-01-26

No results posted yet for this study

Summary

This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy.

Conditions

  • Advanced Biliary Tract Cancer

Interventions

DRUG

Nanoliposomal Irinotecan

Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days

DRUG

Leucovorin

Leucovorin 400 mg/ IV over 30 minutes, every 14 days.

DRUG

Fluorouracil

Fluorouracil 2,400 mg/m IV over 46 hours.

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Benjamin Weinberg, MD · Georgetown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2025-09-03
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04005339 on ClinicalTrials.gov