Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04083235 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
A Phase 3 study of Metastatic Adenocarcinoma of the Pancreas, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 770
- Enrollment target
- 20
- Study locations
NCT04083235 is a Phase 3 study of Metastatic Adenocarcinoma of the Pancreas that has completed, run by Ipsen. The registered enrollment target is 770 participants. The trial reports 20 study locations across 5 states.
The verdict
NCT04083235, a Phase 3 study of Metastatic Adenocarcinoma of the Pancreas, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 770 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Nab-paclitaxel
- DRUG 5Fluorouracil
- DRUG Irinotecan Liposomal Injection
Study Locations (20)
California
- Comprehensive Blood And Cancer Center - Bakersfield
- University of California- Irvine Health Cancer Cente - Costa Mesa
- City of Hope National Medical Center - Duarte
- University of California, Los Angeles (UCLA) - Los Angeles
- St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare - Orange
- University of California - Irvine Medical Center - Orange
- Torrance Memorial Physician Network Cancer Care - Redondo Beach
- Sutter Health Sacramento - Sacramento
- Presbyterian Intercommunity Hospital (PIH) - Whittier
Florida
- Miami Cancer Institute - Miami
- Mount Sinai Medical Center of Florida, Inc. - Miami Beach
- Florida Cancer Specialists - Fort Myers - Sarasota
- Florida Cancer Specialists - Panhandle - Tallahassee
- Florida Cancer Specialists - St. Petersburg - Tampa
- Florida Cancer Specialists - East - West Palm Beach
Arizona
- Banner Health- MD Anderson Cancer Center - Gilbert
- Mayo Clinic - Scottsdale - Phoenix
Colorado
- UC Health Memorial Hospital - Colorado Springs
- Rocky Mountain Cancer Center - Denver
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 770 participants |
| Start Date | 2020-02-11 |
| Est. Completion | 2025-02-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04083235
The ClinicalTrials.gov registry entry for NCT04083235 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 770 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Adenocarcinoma of the Pancreas appearing as the primary indexed condition, and to 5 interventions - of which Leucovorin is the first listed.
NCT04083235 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04083235 about?
NCT04083235 is a clinical study titled "A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment". The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall su...
What is the current status of trial NCT04083235?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 770 participants. The study started on 2020-02-11. Estimated completion is 2025-02-18.
What conditions does trial NCT04083235 study?
This clinical trial studies the following conditions: Metastatic Adenocarcinoma of the Pancreas.
What interventions are being tested in trial NCT04083235?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Nab-paclitaxel (DRUG), 5Fluorouracil (DRUG), Irinotecan Liposomal Injection (DRUG).
Who is sponsoring clinical trial NCT04083235?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04083235 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
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.