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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 is a Phase 2 study that has completed, run by Ipsen. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02551991
The ClinicalTrials.gov registry entry for NCT02551991 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Leucovorin is the first listed.
NCT02551991 reports 0 study locations.
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.
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