Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
Stopped early · Phase 2
Conditions studied: Islet Cell Tumor
In brief
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.
Key facts
- Study ID
- NCT01374451
- Run by
- Novartis Pharmaceuticals
- People needed
- 160
- Starts
- 2011-06-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2016-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor
- Progressive disease within the last 12 months
- Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT
You may not qualify if…
- Patients currently requiring somatostatin analog treatment
- Prior therapy with mTOR inhibitors or pasireotide
- Patients with more than 2 prior systemic treatment regimens
- Previous cytotoxic chemotherapy, targeted therapy, somatostatin analogs, or biotherapy within the last 4 weeks
- Other protocol-defined inclusion/exclusion criteria may apply
Where it is running
- Dana Farber Cancer Institute SC-2 — Boston, Massachusetts, United States
- Montefiore Medical Center MMC — The Bronx, New York, United States
- Oregon Health & Science University Knight Cancer Institute — Portland, Oregon, United States
- University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr — Houston, Texas, United States
- Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
- Novartis Investigative Site — Caba, Buenos Aires, Argentina
- Novartis Investigative Site — St Leonards, New South Wales, Australia
- Novartis Investigative Site — Herston, Queensland, Australia
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Ghent, Belgium
- Novartis Investigative Site — Haine-Saint-Paul, Belgium
- Novartis Investigative Site — Leuven, Belgium
- Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Aarhus, Denmark
- Novartis Investigative Site — Copenhagen N, Denmark
- Novartis Investigative Site — Bordeaux, France
- Novartis Investigative Site — Clichy, France
- Novartis Investigative Site — Lyon, France
- Novartis Investigative Site — Marseille, France
- Novartis Investigative Site — Villejuif, France
- Novartis Investigative Site — Berlin, Germany
Full record on ClinicalTrials.gov
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