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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
NCT04083235 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04083235 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04083235?
This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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