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NCT04005339 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Advanced Biliary Tract Cancer, sponsored by Georgetown University.

Active
Registry status
Phase 2
Development phase
48
Enrollment target
4
Study locations

NCT04005339 is a Phase 2 study of Advanced Biliary Tract Cancer that is active but no longer recruiting, run by Georgetown University. The registered enrollment target is 48 participants. The trial reports 4 study locations across 4 states.

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The verdict

NCT04005339, a Phase 2 study of Advanced Biliary Tract Cancer, is active but no longer recruiting, sponsored by Georgetown University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
48 participants
Enrollment target
4
Study locations

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.

Interventions

  • DRUG Fluorouracil
  • DRUG Leucovorin
  • DRUG Nanoliposomal Irinotecan

Study Locations (4)

District of Columbia

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

Indiana

  • Indiana University Health Melvin and Bren Simon Cancer Center - Indianapolis

Missouri

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

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2019-07-29
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

Georgetown University

227 total trials

What the Registry Record Tells You About NCT04005339

The ClinicalTrials.gov registry entry for NCT04005339 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Biliary Tract Cancer appearing as the primary indexed condition, and to 3 interventions - of which Fluorouracil is the first listed.

NCT04005339 reports 4 study locations spanning 4 distinct geographic areas - top geographies include District of Columbia, Indiana, Missouri.

Frequently Asked Questions

What is clinical trial NCT04005339 about?

NCT04005339 is a clinical study titled "NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer". 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.

What is the current status of trial NCT04005339?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2019-07-29. Estimated completion is 2026-12-31.

What conditions does trial NCT04005339 study?

This clinical trial studies the following conditions: Advanced Biliary Tract Cancer.

What interventions are being tested in trial NCT04005339?

The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Nanoliposomal Irinotecan (DRUG).

Who is sponsoring clinical trial NCT04005339?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04005339 being conducted?

This trial has 4 study locations across District of Columbia, Indiana, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.