NCT04005339View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 29, 2019

Primary Completion Date

December 30, 2025

Study Completion Date

December 31, 2025

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.

Trial Locations (4)

10128

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

20007

RECRUITING

Lombardi Comprehensive Cancer Center, Georgetown University, Washington D.C.

46202

ACTIVE_NOT_RECRUITING

Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis

63110

ACTIVE_NOT_RECRUITING

Washington University School of Medicine- Siteman Cancer Center, St Louis

Sponsors

Collaborators (1)

Ipsen
All Listed Sponsors
collaborator

Ipsen

INDUSTRY

lead

Georgetown University

OTHER