Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
NCT ID: NCT01374451
Last Updated: 2016-12-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
160 participants
INTERVENTIONAL
2011-06-30
2015-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Paseriotide LAR + Everolimus
everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
Everolimus
Everolimus was supplied as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets
Pasireotide LAR
Pasireotide LAR intra-muscular depot injections were supplied as a powder in vials containing 20 mg and 40 mg with ampoules containing 2 mL of vehicle (for reconstitution).
Everolimus
everolimus 10 mg once daily po alone
Everolimus
Everolimus was supplied as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets
Interventions
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Everolimus
Everolimus was supplied as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets
Pasireotide LAR
Pasireotide LAR intra-muscular depot injections were supplied as a powder in vials containing 20 mg and 40 mg with ampoules containing 2 mL of vehicle (for reconstitution).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressive disease within the last 12 months
* Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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Caba, Buenos Aires, Argentina
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St Leonards, New South Wales, Australia
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Herston, Queensland, Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Haine-Saint-Paul, , Belgium
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Leuven, , Belgium
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Rio de Janeiro, Rio de Janeiro, Brazil
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São Paulo, São Paulo, Brazil
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Aarhus, , Denmark
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Copenhagen N, , Denmark
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Bordeaux, , France
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Clichy, , France
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Lyon, , France
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Marseille, , France
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Villejuif, , France
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Berlin, , Germany
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München, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Bologna, BO, Italy
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Milan, MI, Italy
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Modena, MO, Italy
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Fukuoka, Fukuoka, Japan
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Rotterdam, , Netherlands
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Grafton, Auckland, , New Zealand
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Madrid, Madrid, Spain
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Lund, , Sweden
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Uppsala, , Sweden
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Bangkok, , Thailand
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Bangkok, , Thailand
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Ankara, Turkey, Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Cambridge, , United Kingdom
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Glasgow, , United Kingdom
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Manchester, , United Kingdom
Countries
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Other Identifiers
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2010-023183-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSOM230I2201
Identifier Type: -
Identifier Source: org_study_id