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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01374906
First received: June 14, 2011
Last updated: May 14, 2015
Last verified: May 2015
  Purpose

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 Intervention Phase
Cushing's Disease
Drug: SOM230 LAR 30 mg
Drug: SOM230 LAR 10 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of responders in each of the two Pasireotide LAR (long acting release)regimens independently [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    A responder is defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4.

  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Controlled mUFC (mean urinary free cortisol)response of the two Pasireotide regimens by month 7 and 12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To evaluate the frequency of controlled mUFC response of the two Pasireotide regimens by month 7 and 12.


Estimated Enrollment: 150
Study Start Date: November 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374906

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Arizona
ClinTriCo Terminated
Phoenix, Arizona, United States, 85381
United States, California
University of California at Los Angeles UCLA Tiverton Completed
Los Angeles, California, United States, 90095
John Wayne Cancer Center Withdrawn
Santa Monica, California, United States, 90404
Stanford University Medical Center SC Withdrawn
Stanford, California, United States, 94304
Harbor-UCLA Medical Center LA Biomed Terminated
Torrance, California, United States, 90509
United States, Georgia
Emory University School of Medicine/Winship Cancer Institute G2304 - C2301 Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, Maryland
Pituitary Center, Division of Endocrinology SC Active, not recruiting
Baltimore, Maryland, United States, 21287
University of Maryland Medical Center SOM230G2304 Withdrawn
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan Comprehensive Cancer Center SC-2 Active, not recruiting
Ann Arbor, Michigan, United States, 48109-0944
United States, New York
Mount Sinai School of Medicine Mt. Sinai Medical Center Active, not recruiting
New York, New York, United States, 10029
United States, Ohio
Cleveland Clinic SC Withdrawn
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Sciences University DeptofOregonHealth&Sciences(2) Active, not recruiting
Portland, Oregon, United States, 97201
United States, Pennsylvania
University of Pennsylvania - Clinical Studies Unit Unniv SC Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center CSOM230G2304 Terminated
Nashville, Tennessee, United States, 37212-3139
United States, Texas
University of Texas Southwestern Medical Center UT southwest Withdrawn
Dallas, Texas, United States, 75390-8527
United States, Washington
Swedish Medical Center Swedish Terminated
Seattle, Washington, United States
United States, Wisconsin
Medical College of Wisconsin MCW 2 Terminated
Milwaukee, Wisconsin, United States, 53226
Argentina
Novartis Investigative Site Withdrawn
Capital Federal, Buenos Aires, Argentina, 1425EKP
Novartis Investigative Site Withdrawn
Buenos Aires, Argentina, C1232AAC
Novartis Investigative Site Active, not recruiting
Cordoba, Argentina, X5009BSN
Belgium
Novartis Investigative Site Active, not recruiting
Brussel, Belgium, 1090
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1200
Novartis Investigative Site Active, not recruiting
Bruxelles, Belgium, 1070
Novartis Investigative Site Active, not recruiting
Edegem, Belgium, 2650
Novartis Investigative Site Active, not recruiting
Gent, Belgium, 9000
Novartis Investigative Site Active, not recruiting
Leuven, Belgium, 3000
Novartis Investigative Site Withdrawn
Liège, Belgium, 4000
Brazil
Novartis Investigative Site Terminated
Fortaleza, CE, Brazil, 60020-181
Novartis Investigative Site Withdrawn
Belem, PA, Brazil, 66073-000
Novartis Investigative Site Active, not recruiting
Rio de Janeiro, RJ, Brazil, 21941-913
Novartis Investigative Site Withdrawn
Porto Alegre, RS, Brazil, 90035-903
Novartis Investigative Site Withdrawn
Porto Alegre, RS, Brazil, 90560-030
Novartis Investigative Site Completed
Ribeirao Preto, SP, Brazil, 14048-900
Novartis Investigative Site Active, not recruiting
São Paulo, SP, Brazil, 05403 000
Canada, Nova Scotia
Novartis Investigative Site Completed
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Quebec
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H2L 4M1
Novartis Investigative Site Completed
Sherbrooke, Quebec, Canada, J1N 5N4
China, Beijing
Novartis Investigative Site Active, not recruiting
Beijing, Beijing, China, 100730
China, Sichuan
Novartis Investigative Site Active, not recruiting
Chengdu, Sichuan, China, 610041
China
Novartis Investigative Site Completed
Shanghai, China, 200025
Novartis Investigative Site Active, not recruiting
Shanghai, China, 200040
France
Novartis Investigative Site Terminated
Besancon cedex, France, 25030
Novartis Investigative Site Terminated
Caen Cedex9, France, 14033
Novartis Investigative Site Withdrawn
Grenoble Cédex 9, France, 38043
Novartis Investigative Site Terminated
Le Kremlin Bicetre, France, 94275
Novartis Investigative Site Active, not recruiting
LILLE Cedex, France, 59037
Novartis Investigative Site Active, not recruiting
Marseille cedex 05, France, 13385
Novartis Investigative Site Withdrawn
Paris, France, 75014
Novartis Investigative Site Active, not recruiting
Pessac Cedex, France, 33604
Germany
Novartis Investigative Site Completed
Berlin, Germany, 10117
Novartis Investigative Site Completed
Erlangen, Germany, 91054
Novartis Investigative Site Withdrawn
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Hamburg, Germany, 22559
Novartis Investigative Site Active, not recruiting
München, Germany, 80336
Novartis Investigative Site Terminated
Würzburg, Germany, 97080
India
Novartis Investigative Site Active, not recruiting
Mumbai, Maharashtra, India, 400012
Novartis Investigative Site Active, not recruiting
Vellore, Tamil Nadu, India, 632004
Novartis Investigative Site Withdrawn
Chandigarh, India, 160 012
Novartis Investigative Site Terminated
New Delhi, India, 110 029
Israel
Novartis Investigative Site Active, not recruiting
Petach Tikva, Israel, 49100
Italy
Novartis Investigative Site Active, not recruiting
Ancona, AN, Italy, 60126
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20149
Novartis Investigative Site Completed
Milano, MI, Italy, 20162
Novartis Investigative Site Active, not recruiting
Padova, PD, Italy, 35128
Novartis Investigative Site Active, not recruiting
Napoli, Italy, 80131
Japan
Novartis Investigative Site Active, not recruiting
Nagoya, Aichi, Japan, 460-0001
Novartis Investigative Site Terminated
Fukuoka-city, Fukuoka, Japan, 812-8582
Novartis Investigative Site Active, not recruiting
Maebashi-city, Gunma, Japan, 371-8511
Novartis Investigative Site Completed
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site Active, not recruiting
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site Active, not recruiting
Nangoku, Kochi, Japan, 783-8505
Novartis Investigative Site Active, not recruiting
Kyoto-city, Kyoto, Japan, 612-8555
Novartis Investigative Site Active, not recruiting
Osaka-city, Osaka, Japan, 534-0021
Novartis Investigative Site Active, not recruiting
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site Withdrawn
Hamamatsu, Shizuoka, Japan, 431-3192
Novartis Investigative Site Withdrawn
Bunkyo-ku, Tokyo, Japan, 113-8655
Novartis Investigative Site Terminated
Bunkyo-ku, Tokyo, Japan, 113-8603
Novartis Investigative Site Active, not recruiting
Minato-ku, Tokyo, Japan, 105-8470
Novartis Investigative Site Completed
Shinjuku-ku, Tokyo, Japan, 162-8666
Netherlands
Novartis Investigative Site Active, not recruiting
Rotterdam, Netherlands, 3015 CE
Peru
Novartis Investigative Site Withdrawn
Lima, Arequipa, Peru
Novartis Investigative Site Completed
Jesus Maria, Lima, Peru, 11
Novartis Investigative Site Active, not recruiting
Miraflores, Lima, Peru, 18
Poland
Novartis Investigative Site Recruiting
Gdansk, Poland, 80-958
Novartis Investigative Site Completed
Poznan, Poland, 60-355
Novartis Investigative Site Active, not recruiting
Warszawa, Poland, 00-909
Novartis Investigative Site Withdrawn
Warszawa, Poland, 01-809
Novartis Investigative Site Completed
Wroclaw, Poland, 50-367
Russian Federation
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 117036
Novartis Investigative Site Terminated
St.- Petersburg, Russian Federation, 199034
Spain
Novartis Investigative Site Terminated
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site Completed
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site Completed
Pamplona, Navarra, Spain, 31002
Novartis Investigative Site Active, not recruiting
Barcelona, Spain, 08025
Thailand
Novartis Investigative Site Completed
Bangkok, Thailand, 10330
Novartis Investigative Site Withdrawn
Bangkok, Thailand, 10700
Novartis Investigative Site Withdrawn
Songkla, Thailand, 90110
Turkey
Novartis Investigative Site Active, not recruiting
Balcova / Izmir, Turkey, 35340
Novartis Investigative Site Active, not recruiting
Diskapi / Ankara, Turkey, 06110
Novartis Investigative Site Active, not recruiting
Fatih / Istanbul, Turkey, 34098
United Kingdom
Novartis Investigative Site Terminated
Salford, Manchester, United Kingdom, M6 8HD
Novartis Investigative Site Withdrawn
Birmingham, United Kingdom, B15 2TH
Novartis Investigative Site Terminated
Norwich, United Kingdom, NR4 7UY
Novartis Investigative Site Active, not recruiting
Sheffield, United Kingdom, S5 7AU
Novartis Investigative Site Terminated
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01374906     History of Changes
Other Study ID Numbers: CSOM230G2304
Study First Received: June 14, 2011
Last Updated: May 14, 2015
Health Authority: United States: Food and Drug Administration
Netherlands: Medicines Evaluation Board (MEB)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation
Turkey: Ministry of Health
China: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Canada: Ministry of Health & Long Term Care, Ontario
Brazil: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Thailand: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare
India: Drugs Controller General of India
Israel: Ministry of Health
Peru: Instituto Nacional de Salud

Keywords provided by Novartis:
Cushing's Disease
Mean Urinary Free Cortisol
Pasireotide

Additional relevant MeSH terms:
Adrenocortical Hyperfunction
Cushing Syndrome
Pituitary ACTH Hypersecretion
Adrenal Gland Diseases
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on August 30, 2015