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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: Active Phase 2 study of Advanced Biliary Tract Cancer, sponsored by Georgetown University.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as positive if there is no evidence of disease progression (PD) at 4 months, as measured by RECIST v1.1 criteria
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-07-29 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04005339 still lists
NCT04005339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Advanced Biliary Tract Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04005339's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer
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The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers
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