Trial · NCT05546853
Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma
NCT05546853, Phase 1, Completed, University Hospital, Grenoble
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma. Trials, record NCT05546853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05546853
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma
- NCT number
- NCT05546853
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 43 participants, actual
- Lead sponsor
- University Hospital, Grenoble
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Interventions
- NP137, Oxaliplatin, Irinotecan, Calcium levofolinate, 5 FU
- First posted
- 2022-09-21
- Last updated
- 2026-05-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Proportion of patients experiencing adverse events | At 6 months | Percentage Proportion of patients experiencing adverse events (AEs) of any grade and grade 3/4 AEs as defined by the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE v 5.0) at 6 months. |
| Secondary | Best overall objective response rate (ORR) | At 3,6,9 and 12 months | Best overall objective response rate (ORR) and ORR at 3 months, 6, 9, 12 months according to RECIST 1.1 |
| Secondary | Overall survival (OS) | at 6, 12 and 36 months | Median Overall survival (OS), 6 months and 12 months-OS rates. OS is defined as the time between inclusion and death (all causes). Patients alive will be censored at the date of last news. |
| Secondary | Progression-Free Survival (PFS) | at 6, 12 and 36 months | Median Progression-Free Survival (PFS), 6 months and 12 months-PFS rates. PFS is defined as the time between inclusion and progression according to RECIST 1.1 or death (all causes). Patients alive without progression will be censored at the date of last news. |
| Secondary | Median Duration of response | at 6 and 36 months | Median Duration of response is defined as the time between first dose of treatment and progression according to RECIST 1.1. Patients alive without progression will be censored at 6 months and at the date of last news. |
| Secondary | Quality of life (QoL) | at 6 and 36 months | Quality of life will be studied by using the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire for Cancer) at 6 months and at the end of study. A 5-point decrease of QLQ-C30 score will be considered as the minimal clinically significant deterioration of QoL. |
| Secondary | time to deterioration | at 6 and 36 months | TTD will be defined as the time from inclusion in the study to deterioration of EORTC QLQ-C30 score with a decrease ≥5 points at any time point after the baseline score, at 6 months and at the end of study |
| Secondary | PK-PD evaluation | at 36 months | PK-PD evaluation: based on available PopPK modelisation and PK samples collected at the time of the response evaluation in this study |
| Secondary | CA19.9 response | at 6 and 12 months | CA19.9 response will be defined as a percentage of patients with a ≥ 50% reduction from baseline CA19.9 level, at 6 and 12 months. |
| Secondary | proportion of patients reaching surgery | at 6 and 36 months | Percentage surgical resection with R0/R1 margins at 6 months and at the end of study. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42020751 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05546853
GET https://conductscience.org/api/trials/v1/NCT05546853/registered