Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Public ClinicalTrials.gov record NCT02551991. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-label Phase 2 Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-Paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, phase 2 non-comparative study to assess the safety, tolerability, and preliminary efficacy of nal-IRI in combination with other anticancer therapies in patients not previously treated for metastatic pancreatic adenocarcinoma. This study will assess the following regimen: • nal-IRI + 5-fluorouracil (5-FU)/leucovorin (LV) + oxaliplatin The study will be conducted in two parts: Part 1, consisting of an initial dose exploration (Part 1A) followed by dose expansion (Part 1B) of the irinotecan liposome injection +5-FU/LV + oxaliplatin regimen and Part 2, consisting of a comparison of irinotecan liposome injection-containing regimen versus nab-paclitaxel plus gemcitabine. The comparative Part 2 was removed in a protocol amendment, dated 11 April 2018 (Version 6.0), before it was initiated, as this comparative part of the study is being undertaken as a stand-alone phase III study D-US-60010-001. This CSR only pertains to the single-arm dose exploration and dose expansion Part 1 results and no further reference is made to the comparative Part 2.
Study identification
- NCT ID
- NCT02551991
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 18, 2015
- Primary completion
- Feb 14, 2021
- Completion
- Feb 14, 2021
- Last update posted
- Oct 9, 2022
2015 – 2021
United States locations
- U.S. sites
- 29
- U.S. states
- 19
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36604 | — |
| University of South Alabama - Mobile | Mobile | Alabama | 36688 | — |
| Arizona Center for Cancer Care | Avondale | Arizona | 85392 | — |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| UCLA Hematology Oncology - Ventura | Los Angeles | California | 90095 | — |
| University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of Colorado (CU) Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | — |
| Mayo Clinic Cancer Center | Jacksonville | Florida | 32224 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Eastern Maine Medical Cancer Care | Brewer | Maine | 04412 | — |
| Maryland Oncology Hematology | Silver Spring | Maryland | 20904 | — |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | — |
| Mayo Clinic Cancer Center - Rochester | Rochester | Minnesota | 55905 | — |
| Oncology Hematology West PC dba Nebraska | Omaha | Nebraska | 68130 | — |
| US Oncology - Comprehensive Cancer Centers of Nevada (CCCN) | Las Vegas | Nevada | 89169 | — |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Oncology/Hematology Care Clinical Trials, LLC | Cincinnati | Ohio | 45230 | — |
| University of Oklahoma Health Sciences Center (OUHSC) Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Willamette Valley Cancer Institute & Research Center | Eugene | Oregon | 97401 | — |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | — |
| Greenville Health System | Greenville | South Carolina | 29605 | — |
| Medical Group of the Carolinas - Spartanburg Regional Health Services | Spartanburg | South Carolina | 29303 | — |
| Texas Oncology Methodist Dallas Cancer Center | Dallas | Texas | 75203 | — |
| Texas Oncology-Fort Worth 12 Ave | Fort Worth | Texas | 76104 | — |
| Houston Methodist Cancer Center and Institute of Academic Medicine | Houston | Texas | 77030 | — |
| Oncology Consultants - Houston | Houston | Texas | 77030 | — |
| Joe Arrington Cancer Research and Treatment Center - Lubbock | Lubbock | Texas | 79410 | — |
| Texas Oncology, P.A. | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02551991, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2022 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02551991 live on ClinicalTrials.gov.