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NCT03483038 · ClinicalTrials.gov registry record · Phase 2

A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

A Phase 2 study of Pancreatic Adenocarcinoma, sponsored by University of Florida.

Active
Registry status
Phase 2
Development phase
45
Enrollment target
4
Study locations

NCT03483038 is a Phase 2 study of Pancreatic Adenocarcinoma that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 45 participants, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 2 states.

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The verdict

NCT03483038, a Phase 2 study of Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by University of Florida.

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

Study Summary

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Conditions Studied

Interventions

  • DRUG FOLFOX regimen
  • DRUG Liposomal Irinotecan

Study Locations (4)

Florida

  • University of Florida - Gainesville
  • Orlando Health UF Health Cancer Center - Orlando
  • Tallahassee Memorial Health Care - Tallahassee

Indiana

  • Indiana University Melvin and Bren Simon Cancer Center - Indianapolis

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2018-12-13
Est. Completion 2026-12
Phase Phase 2

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT03483038

The ClinicalTrials.gov registry entry for NCT03483038 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which FOLFOX regimen is the first listed.

NCT03483038 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Florida, Indiana.

Frequently Asked Questions

What is clinical trial NCT03483038 about?

NCT03483038 is a clinical study titled "A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma". This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and f...

What is the current status of trial NCT03483038?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2018-12-13. Estimated completion is 2026-12.

What conditions does trial NCT03483038 study?

This clinical trial studies the following conditions: Pancreatic Adenocarcinoma.

What interventions are being tested in trial NCT03483038?

The interventions under investigation include: FOLFOX regimen (DRUG), Liposomal Irinotecan (DRUG).

Who is sponsoring clinical trial NCT03483038?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03483038 being conducted?

This trial has 4 study locations across Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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