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NCT02551991 · ClinicalTrials.gov registry record · Phase 2
Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
A Phase 2 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT02551991: Completed Phase 2 study, sponsored by Ipsen.
NCT02551991 is a Phase 2 study that has completed, run by Ipsen. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02551991, a Phase 2 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Adverse events (AEs) were considered to be DLTs if they occurred during the safety evaluation period (i.e, 28 days of Cycle 1; or 14 days after the second dose of study treatment if there was a treatment delay) and were deemed related to the study treatment regimen. Any AE that was related to disease progression was not considered a DLT.
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG 5 fluorouracil
- DRUG nal-IRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-10-19 |
| Est. Completion | 2021-02-15 |
| Phase | Phase 2 |
What the finished NCT02551991 record still lists
NCT02551991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 4 interventions - of which Leucovorin is the first listed.
NCT02551991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02551991 about?
NCT02551991 is a clinical study titled "Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma". 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: • na...
What is the current status of trial NCT02551991?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2015-10-19. Estimated completion is 2021-02-15.
What interventions are being tested in trial NCT02551991?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), 5 fluorouracil (DRUG), nal-IRI (DRUG).
Who is sponsoring clinical trial NCT02551991?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02551991's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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