Chief Cushie ~MaryO~ Posted September 7, 2012 Chief Cushie Report Share Posted September 7, 2012 This study is currently recruiting participants. Verified August 2012 by Novartis First Received on June 14, 2011. Last Updated on August 23, 2012 History of Changes Sponsor: Novartis Pharmaceuticals Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals ) ClinicalTrials.gov Identifier: NCT01374906 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: Genetics Home Reference related topics: Cushing disease MedlinePlus related topics: Cushing's SyndromeU.S. FDA Resources 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: 148 Study Start Date: November 2011 Estimated Study Completion Date: January 2016 Estimated Primary Completion Date: November 2015 (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. [/url] 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 Please refer to this study by its ClinicalTrials.gov identifier: NCT01374906 Contacts Contact: Novartis Pharmaceuticals +1(800)340-6843 Show 73 Study Locations 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: August 23, 2012 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 and Social Development of the Russian Federation Turkey: Ministry of Health China: State 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 Keywords provided by Novartis: Cushing's Disease Mean Urinary Free Cortisol Pasireotide Additional relevant MeSH terms: Cushing Syndrome Pituitary ACTH Hypersecretion Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases ClinicalTrials.gov processed this record on September 06, 2012 Locations United States, California UCLA/ University of California Los Angeles UCLA Tiverton Recruiting Los Angeles, California, United States, 90095 Contact: Brittany Sumerel 310-825-5874 firstname.lastname@example.org Principal Investigator: Anthony P. Heaney United States, Maryland Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Sidnney Kimmel J Hopkins Not yet recruiting Baltimore, Maryland, United States, 21231 Contact: Thomas Mitchell 410-502-0033 email@example.com Principal Investigator: Roberto Salvatori United States, Ohio Cleveland Clinic Foundation CCF - Euclid Loc Withdrawn Cleveland, Ohio, United States, 44195 United States, Oregon Oregon Health & Sciences University OHSU Withdrawn Portland, Oregon, United States, 97201 United States, Pennsylvania University of Pennsylvania - Clinical Studies Unit Unniv SC Not yet recruiting Philadelphia, Pennsylvania, United States, 19104 Contact: Kenneth Rockwell, Jr. 215-898-5664 firstname.lastname@example.org Principal Investigator: Peter J. Snyder 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 Recruiting Milwaukee, Wisconsin, United States, 53226 Contact: Gerard Coly 414-456-7468 email@example.com Principal Investigator: James W. Findling Argentina Novartis Investigative Site Withdrawn Capital Federal, Buenos Aires, Argentina, 1425EKP Novartis Investigative Site Not yet recruiting Buenos Aires, Argentina, C1232AAC Novartis Investigative Site Not yet recruiting Cordoba, Argentina, X5009BSN Belgium Novartis Investigative Site Recruiting Bruxelles, Belgium, 1200 Novartis Investigative Site Recruiting Bruxelles, Belgium, 1070 Novartis Investigative Site Recruiting Edegem, Belgium, 2650 Novartis Investigative Site Recruiting Gent, Belgium, 9000 Novartis Investigative Site Recruiting Jette, Belgium, 1090 Novartis Investigative Site Recruiting Leuven, Belgium, 3000 Novartis Investigative Site Recruiting Liège, Belgium, 4000 Brazil Novartis Investigative Site Not yet recruiting Fortaleza, CE, Brazil, 60020-181 Novartis Investigative Site Not yet recruiting Rio de Janeiro, RJ, Brazil, 21941-913 Novartis Investigative Site Not yet recruiting Porto Alegre, RS, Brazil, 90035-903 Novartis Investigative Site Not yet recruiting Ribeirao Preto, SP, Brazil, 14048-900 Novartis Investigative Site Recruiting São Paulo, SP, Brazil, 05403 000 Canada, Nova Scotia Novartis Investigative Site Recruiting Halifax, Nova Scotia, Canada, B3H 1V7 Canada, Quebec Novartis Investigative Site Recruiting Montreal, Quebec, Canada, H2L 4M1 Novartis Investigative Site Recruiting Sherbrooke, Quebec, Canada, J1N 5N4 France Novartis Investigative Site Recruiting Besancon cedex, France, 25030 Novartis Investigative Site Recruiting Caen Cedex9, France, 14033 Novartis Investigative Site Recruiting Grenoble Cédex 9, France, 38043 Novartis Investigative Site Recruiting Le Kremlin Bicetre, France, 94275 Novartis Investigative Site Recruiting LILLE Cedex, France, 59037 Novartis Investigative Site Recruiting Marseille cedex 05, France, 13385 Novartis Investigative Site Recruiting Paris, France, 75006 Novartis Investigative Site Recruiting Pessac Cedex, France, 33604 Germany Novartis Investigative Site Recruiting Berlin, Germany, 10117 Novartis Investigative Site Not yet recruiting Erlangen, Germany, 91054 Novartis Investigative Site Recruiting Hamburg, Germany, 22559 Novartis Investigative Site Recruiting München, Germany, 80336 Novartis Investigative Site Recruiting Würzburg, Germany, 97080 Italy Novartis Investigative Site Recruiting Ancona, AN, Italy, 60126 Novartis Investigative Site Recruiting Milano, MI, Italy, 20162 Novartis Investigative Site Recruiting Milano, MI, Italy, 20149 Novartis Investigative Site Recruiting Padova, PD, Italy, 35128 Novartis Investigative Site Recruiting Napoli, Italy, 80131 Japan Novartis Investigative Site Recruiting Maebashi, Gunma, Japan, 371-8511 Novartis Investigative Site Recruiting Kyoto-city, Kyoto, Japan, 612-8555 Novartis Investigative Site Recruiting Suita-city, Osaka, Japan, 565-0871 Novartis Investigative Site Recruiting Hamamatsu, Shizuoka, Japan, 431-3192 Novartis Investigative Site Recruiting Bunkyo-ku, Tokyo, Japan, 113-8655 Novartis Investigative Site Recruiting Bunkyo-ku, Tokyo, Japan, 113-8603 Novartis Investigative Site Recruiting Minato-ku, Tokyo, Japan, 105-8470 Novartis Investigative Site Recruiting Shinjuku-ku, Tokyo, Japan, 162-8666 Netherlands Novartis Investigative Site Recruiting Rotterdam, Netherlands, 3015 CE Peru Novartis Investigative Site Not yet recruiting Jesus Maria, Lima, Peru, 11 Novartis Investigative Site Not yet recruiting Miraflores, Lima, Peru, 18 Poland Novartis Investigative Site Not yet recruiting Poznan, Poland, 60-355 Novartis Investigative Site Not yet recruiting Warszawa, Poland, 01-809 Novartis Investigative Site Recruiting Wroclaw, Poland, 50-367 Russian Federation Novartis Investigative Site Not yet recruiting Moscow, Russian Federation, 117036 Novartis Investigative Site Not yet recruiting St.- Petersburg, Russian Federation, 199034 Spain Novartis Investigative Site Recruiting Sevilla, Andalucía, Spain, 41013 Novartis Investigative Site Recruiting Barcelona, Cataluña, Spain, 08025 Novartis Investigative Site Recruiting Alzira, Comunidad Valenciana, Spain, 46600 Novartis Investigative Site Recruiting Pamplona, Navarra, Spain, 31002 Thailand Novartis Investigative Site Recruiting Bangkok, Thailand, 10700 Novartis Investigative Site Recruiting Bangkok, Thailand, 10330 Turkey Novartis Investigative Site Not yet recruiting Diskapi / Ankara, Turkey, 06110 Novartis Investigative Site Not yet recruiting Istanbul, Turkey, 34303 Novartis Investigative Site Not yet recruiting Izmir, Turkey, 35340 United Kingdom Novartis Investigative Site Recruiting Salford, Manchester, United Kingdom, M6 8HD Novartis Investigative Site Recruiting Norwich, United Kingdom, NR4 7UY Novartis Investigative Site Recruiting Sheffield, United Kingdom, S5 7AU Novartis Investigative Site Recruiting Southampton, United Kingdom, SO16 6YD Quote Link to comment Share on other sites More sharing options...
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