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Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

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ClinicalTrials.gov Identifier: NCT01374906
Recruitment Status : Completed
First Posted : June 16, 2011
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

Condition or disease Intervention/treatment Phase
Cushing's Disease Drug: SOM230 LAR 30 mg Drug: SOM230 LAR 10 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease
Actual Study Start Date : November 4, 2011
Primary Completion Date : November 22, 2016
Study Completion Date : November 22, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 10 mg LAR dose Drug: SOM230 LAR 10 mg
starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.
Experimental: 30 mg LAR dose Drug: SOM230 LAR 30 mg
starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose.

Primary Outcome Measures :
  1. Proportion of responders in each of the two Pasireotide LAR (long acting release)regimens independently [ Time Frame: 7 months ]
    To assess the efficacy of two Pasireotide LAR (long acting release) regimens independently in patients with Cushing's disease after 7 months of treatment regardless of up titration at month 4. A responder is defined as a patient who attains Mean Urinary Free Cortisol (mUFC) ≤ 1.0 X Upper Limit of Normal (ULN) at month 7 regardless of dose-titration.

Secondary Outcome Measures :
  1. Proportion of responders in each of the Pasireotide LAR (long acting release) 10 mg and 30 mg doses independently in patients with Cushing's disease after 7 months of treatment who did not up titrate the doses of Pasireotide at month 4. [ Time Frame: 7 months ]
    A responder is defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4.

  2. Change in mean urinary free cortisol from baseline at every month in the core and every 3 months in extension within the two Pasireotide LAR regimens [ Time Frame: 26 months ]
  3. Proportion of responders in the two Pasireotide LAR regimens at every month in the core and every 3 months in the extension phases [ Time Frame: 26 months ]
  4. Proportion of responders in the two Pasireotide LAR regimens as measured by controlled and partially controlled mUFC(mean urinary free cortisol) combined responders at every month in the core and every 3 months in the extension [ Time Frame: 26 months ]
  5. Controlled mUFC (mean urinary free cortisol)response of the two Pasireotide regimens by month 7 and 12 [ Time Frame: 12 months ]
    To evaluate the frequency of controlled mUFC response of the two Pasireotide regimens by month 7 and 12.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
  • For patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed

    • Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week
    • Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks
    • Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks
    • Octreotide (immediate release formulation): 1 week

Exclusion Criteria:

  • Patients who are considered candidates for surgical treatment at the time of study entry
  • Patients who have received pituitary irradiation within the last ten years prior to visit 1
  • Patients who have had any previous pasireotide treatment
  • Patients who have been treated with mitotane during the last 6 months prior to Visit 1
  • Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c >8%
  • Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF >470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval
  • Female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. Sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374906

  Hide Study Locations
United States, Arizona
Phoenix, Arizona, United States, 85381
United States, California
University of California at Los Angeles UCLA Tiverton
Los Angeles, California, United States, 90095
Harbor-UCLA Medical Center LA Biomed
Torrance, California, United States, 90509
United States, Georgia
Emory University School of Medicine/Winship Cancer Institute G2304 - C2301
Atlanta, Georgia, United States, 30322
United States, Maryland
Pituitary Center, Division of Endocrinology SC
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan Comprehensive Cancer Center SC-2
Ann Arbor, Michigan, United States, 48109-0944
United States, New York
Mount Sinai School of Medicine Mt. Sinai Medical Center
New York, New York, United States, 10029
United States, Oregon
Oregon Health & Sciences University DeptofOregonHealth&Sciences(2)
Portland, Oregon, United States, 97201
United States, Pennsylvania
University of Pennsylvania - Clinical Studies Unit Unniv SC
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center CSOM230G2304
Nashville, Tennessee, United States, 37212-3139
United States, Washington
Swedish Medical Center Swedish
Seattle, Washington, United States
United States, Wisconsin
Medical College of Wisconsin MCW 2
Milwaukee, Wisconsin, United States, 53226
Novartis Investigative Site
Buenos Aires, Argentina, C1232AAC
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Cordoba, Argentina, X5009BSN
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Brussel, Belgium, 1090
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Bruxelles, Belgium, 1070
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Edegem, Belgium, 2650
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
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Fortaleza, CE, Brazil, 60020-181
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Rio de Janeiro, RJ, Brazil, 21941-913
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São Paulo, SP, Brazil, 05403 000
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Quebec
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Montreal, Quebec, Canada, H2L 4M1
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Sherbrooke, Quebec, Canada, J1N 5N4
China, Beijing
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Beijing, Beijing, China, 100730
China, Sichuan
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Chengdu, Sichuan, China, 610041
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Shanghai, China, 200025
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Shanghai, China, 200040
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Besancon cedex, France, 25030
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Caen Cedex9, France, 14033
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Le Kremlin Bicetre, France, 94275
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Lille Cedex, France, 59037
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Marseille Cédex 5, France, 13385
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Pessac Cedex, France, 33604
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Berlin, Germany, 10117
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Erlangen, Germany, 91054
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München, Germany, 80336
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Würzburg, Germany, 97080
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Mumbai, Maharashtra, India, 400012
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Vellore, Tamil Nadu, India, 632004
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New Delhi, India, 110 029
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Petach Tikva, Israel, 49100
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Ancona, AN, Italy, 60126
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Milano, MI, Italy, 20149
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Milano, MI, Italy, 20162
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Padova, PD, Italy, 35128
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Napoli, Italy, 80131
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Nagoya, Aichi, Japan, 460-0001
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Fukuoka city, Fukuoka, Japan, 812-8582
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Maebashi-city, Gunma, Japan, 371-8511
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Sapporo-city, Hokkaido, Japan, 060-8648
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Kobe-city, Hyogo, Japan, 650-0017
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Nankoku-city, Kochi, Japan, 783-8505
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Kyoto-city, Kyoto, Japan, 612-8555
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Osaka-city, Osaka, Japan, 534-0021
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Suita-city, Osaka, Japan, 565-0871
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Bunkyo-ku, Tokyo, Japan, 113-8603
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Minato-ku, Tokyo, Japan, 105-8470
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Shinjuku-ku, Tokyo, Japan, 162-8666
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Rotterdam, Netherlands, 3015 CE
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Jesus Maria, Lima, Peru, 11
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Miraflores, Lima, Peru, 18
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Gdansk, Poland, 80-952
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Poznan, Poland, 60-355
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Warszawa, Poland, 00-909
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Wroclaw, Poland, 50-367
Russian Federation
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Moscow, Russian Federation, 117036
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St.- Petersburg, Russian Federation, 199034
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site
Barcelona, Spain, 08041
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10700
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Balcova / Izmir, Turkey, 35340
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Diskapi / Ankara, Turkey, 06110
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Fatih / Istanbul, Turkey, 34098
United Kingdom
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Salford, Manchester, United Kingdom, M6 8HD
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Norwich, United Kingdom, NR4 7UY
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Sheffield, United Kingdom, S5 7AU
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Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01374906     History of Changes
Other Study ID Numbers: CSOM230G2304
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cushing's Disease
Mean Urinary Free Cortisol

Additional relevant MeSH terms:
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs