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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: Completed Phase 3 study of Metastatic Adenocarcinoma of the Pancreas, sponsored by Ipsen.
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, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The OS was defined as time from the date of randomization to the date of death due to any cause. Participants who did not have a date of death recorded at the time of the final analysis were censored at the last known time that the participant was alive. The median OS was measured using Kaplan-Meier technique.
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 |
What the finished NCT04083235 record still lists
NCT04083235 is an interventional study that assigns participants to a tested intervention. The registered 770 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
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 names 20 study sites across 5 states, led by 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
How this trial's enrollment target compares
Where NCT04083235's enrollment target sits among peer trials
770 440th of 2000 higher than 1,557 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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