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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: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01374451 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS per RECIST 1.0. (Response Evaluation Criteria in Solid Tumors). PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
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 |
Why NCT01374451 stopped before completion
NCT01374451 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT01374451 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01374451's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 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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