Trial · NCT04083235
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, Phase 3, Completed, Ipsen; results first posted 2024-03-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT04083235. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04083235
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT04083235
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 770 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Metastatic Adenocarcinoma of the Pancreas
- Interventions
- Irinotecan Liposomal Injection, Oxaliplatin, 5Fluorouracil, Leucovorin, Nab-paclitaxel, Gemcitabine
- First posted
- 2019-09-10
- Last updated
- 2026-04-20
- Other registries' IDs
- eudract:2018-003585-14
- Results first posted
- 2024-03-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to primary completion date (PCD) of 23 July 2022 (maximum of 893 days) | 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. |
| Secondary | Progression Free Survival (PFS) | Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022 (maximum of 893 days) | PFS was defined as the time from the date of randomization to the first documented disease progression using response evaluation criteria in solid tumors (RECIST) Version 1.1 as per Investigator assessment or death due to any cause. The median PFS was measured using Kaplan-Meier technique. |
| Secondary | Overall Response Rate (ORR) | Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022, (maximum of 893 days) | The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to primary completion date (PCD) of 23 July 2022 (maximum of 893 days) | The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022 (maximum of 893 days) | The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization. Only participants with PFS event are reported. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022, (maximum of 893 days) | The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | NALIRIFOX | 11.1 | 95% Confidence Interval 10.0 to 12.1 | months | |
| Overall Survival (OS) | Nab-paclitaxel+Gemcitabine | 9.2 | 95% Confidence Interval 8.3 to 10.6 | months | |
| Progression Free Survival (PFS) | NALIRIFOX | 7.4 | 95% Confidence Interval 6.0 to 7.7 | months | |
| Progression Free Survival (PFS) | Nab-paclitaxel+Gemcitabine | 5.6 | 95% Confidence Interval 5.3 to 5.8 | months | |
| Overall Response Rate (ORR) | NALIRIFOX | 41.8 | 95% Confidence Interval 36.8 to 46.9 | percentage of participants | |
| Overall Response Rate (ORR) | Nab-paclitaxel+Gemcitabine | 36.2 | 95% Confidence Interval 31.4 to 41.2 | percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NALIRIFOX | 383 | |
| Overall Study | STARTED | Nab-paclitaxel+Gemcitabine | 387 | |
| Overall Study | Received Treatment | NALIRIFOX | 370 | |
| Overall Study | Received Treatment | Nab-paclitaxel+Gemcitabine | 379 | |
| Overall Study | COMPLETED | NALIRIFOX | 0 | |
| Overall Study | COMPLETED | Nab-paclitaxel+Gemcitabine | 0 | |
| Overall Study | NOT COMPLETED | NALIRIFOX | 383 | |
| Overall Study | NOT COMPLETED | Nab-paclitaxel+Gemcitabine | 387 |
Source ClinicalTrials.gov
Adverse events600
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | NALIRIFOX | 257 | 370 | 580 |
| other | Diarrhoea | Gastrointestinal disorders | Nab-paclitaxel+Gemcitabine | 136 | 379 | 221 |
| other | Nausea | Gastrointestinal disorders | NALIRIFOX | 216 | 370 | 417 |
| other | Nausea | Gastrointestinal disorders | Nab-paclitaxel+Gemcitabine | 161 | 379 | 219 |
| other | Vomiting | Gastrointestinal disorders | NALIRIFOX | 140 | 370 | 227 |
| other | Vomiting | Gastrointestinal disorders | Nab-paclitaxel+Gemcitabine | 95 | 379 | 169 |
| other | Stomatitis | Gastrointestinal disorders | NALIRIFOX | 54 | 370 | 94 |
| other | Stomatitis | Gastrointestinal disorders | Nab-paclitaxel+Gemcitabine | 45 | 379 | 54 |
| other | Constipation | Gastrointestinal disorders | NALIRIFOX | 96 | 370 | 119 |
| other | Constipation | Gastrointestinal disorders | Nab-paclitaxel+Gemcitabine | 111 | 379 | 140 |
1 to 10 of 600Source ClinicalTrials.gov
See all 600 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NALIRIFOX | 345 | 370 |
| Total, all-cause mortality | Nab-paclitaxel+Gemcitabine | 359 | 379 |
| Total, other adverse events | NALIRIFOX | 364 | 370 |
| Total, other adverse events | Nab-paclitaxel+Gemcitabine | 371 | 379 |
| Total, serious adverse events | NALIRIFOX | 207 | 370 |
| Total, serious adverse events | Nab-paclitaxel+Gemcitabine | 198 | 379 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NALIRIFOX vs Nab-paclitaxel+Gemcitabine: deaths from any cause | Trial comparisons |
| NALIRIFOX vs Nab-paclitaxel+Gemcitabine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04083235
GET https://conductscience.org/api/trials/v1/NCT04083235/events?page=2