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NCT01374451 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT01374451 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 160 participants.
The verdict
NCT01374451, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET. A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.
Interventions
- DRUG Everolimus
- DRUG Pasireotide LAR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01374451
The ClinicalTrials.gov registry entry for NCT01374451 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT01374451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01374451 about?
NCT01374451 is a clinical study titled "Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET". This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET. A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet i...
What is the current status of trial NCT01374451?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2011-06. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01374451?
The interventions under investigation include: Everolimus (DRUG), Pasireotide LAR (DRUG).
Who is sponsoring clinical trial NCT01374451?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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