Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
NCT ID: NCT00434148
Last Updated: 2016-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
162 participants
INTERVENTIONAL
2006-12-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pasireotide 600 ug
At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was \<= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
Pasireotide
Pasireotide 900 ug
At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was \<= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
Pasireotide
Interventions
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Pasireotide
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of ACTH-dependent Cushing's disease
* Not considered candidate for pituitary surgery
Exclusion Criteria
* Cushing's syndrome not caused by pituitary tumor
* Patients with active malignant disease (cancer) in the last 5 years
* Women who are pregnant or lactating
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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Stanford University Medical Center Stanford Cancer Center (3)
Stanford, California, United States
University Chicago Hospital Dept. of Univ of Chicago
Chicago, Illinois, United States
Dana Farber Cancer Institute The Melanoma Program
Boston, Massachusetts, United States
Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed
New York, New York, United States
Cleveland Clinic Foundation Dept. of Cleveland Clinic (6)
Cleveland, Ohio, United States
Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.
Portland, Oregon, United States
University of Texas Southwestern Medical Center Clinical-TranslationalRes.Ctr.
Dallas, Texas, United States
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Seattle, Washington, United States
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Edegem, , Belgium
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Ghent, , Belgium
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Ribeirão Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
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Beijing, Beijing Municipality, China
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Beijing, , China
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Shanghai, , China
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Aarhus, , Denmark
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Copenhagen, , Denmark
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Herlev, , Denmark
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Helsinki, , Finland
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Angers, , France
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Grenoble Cédex 9, , France
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Lille, , France
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Limoges, , France
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Marseille, , France
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Paris, , France
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Pessac, , France
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Saint-Priest-en-Jarez, , France
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Toulouse, , France
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München, Germany, Germany
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Berlin, , Germany
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Essen, , Germany
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Würzburg, , Germany
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Athens, GR, Greece
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Athens, GR, Greece
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ancona, AN, Italy
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Cona, FE, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Padua, PD, Italy
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Pisa, PI, Italy
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Orbassano, TO, Italy
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Torino, TO, Italy
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Napoli, , Italy
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Warsaw, , Poland
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Porto, Portugal, Portugal
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Seville, Andalusia, Spain
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Barcelona, Barcelona, Spain
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Ankara, , Turkey (Türkiye)
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Balcova / Izmir, , Turkey (Türkiye)
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Fatih / Istanbul, , Turkey (Türkiye)
Countries
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References
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Lacroix A, Gu F, Schopohl J, Kandra A, Pedroncelli AM, Jin L, Pivonello R. Pasireotide treatment significantly reduces tumor volume in patients with Cushing's disease: results from a Phase 3 study. Pituitary. 2020 Jun;23(3):203-211. doi: 10.1007/s11102-019-01021-2.
Yedinak CG, Hopkins S, Williams J, Ibrahim A, Cetas JS, Fleseriu M. Medical Therapy with Pasireotide in Recurrent Cushing's Disease: Experience of Patients Treated for At Least 1 Year at a Single Center. Front Endocrinol (Lausanne). 2017 Feb 27;8:35. doi: 10.3389/fendo.2017.00035. eCollection 2017.
Schopohl J, Gu F, Rubens R, Van Gaal L, Bertherat J, Ligueros-Saylan M, Trovato A, Hughes G, Salgado LR, Boscaro M, Pivonello R; Pasireotide B2305 Study Group. Pasireotide can induce sustained decreases in urinary cortisol and provide clinical benefit in patients with Cushing's disease: results from an open-ended, open-label extension trial. Pituitary. 2015 Oct;18(5):604-12. doi: 10.1007/s11102-014-0618-1.
MacKenzie Feder J, Bourdeau I, Vallette S, Beauregard H, Ste-Marie LG, Lacroix A. Pasireotide monotherapy in Cushing's disease: a single-centre experience with 5-year extension of phase III Trial. Pituitary. 2014 Dec;17(6):519-29. doi: 10.1007/s11102-013-0539-4.
Petersenn S, Newell-Price J, Findling JW, Gu F, Maldonado M, Sen K, Salgado LR, Colao A, Biller BM; Pasireotide B2305 Study Group. High variability in baseline urinary free cortisol values in patients with Cushing's disease. Clin Endocrinol (Oxf). 2014 Feb;80(2):261-9. doi: 10.1111/cen.12259. Epub 2013 Jul 15.
Colao A, Petersenn S, Newell-Price J, Findling JW, Gu F, Maldonado M, Schoenherr U, Mills D, Salgado LR, Biller BM; Pasireotide B2305 Study Group. A 12-month phase 3 study of pasireotide in Cushing's disease. N Engl J Med. 2012 Mar 8;366(10):914-24. doi: 10.1056/NEJMoa1105743.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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2006-004111-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSOM230B2305
Identifier Type: -
Identifier Source: org_study_id
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