An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (MACS1599)
This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01582061
First received: April 12, 2012
Last updated: March 22, 2013
Last verified: March 2013
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Purpose
This study will document the safety and efficacy of pasireotide s.c. in patients with Cushing's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Cushing's Disease |
Drug: Pasireotide sub-cutaneous formulation |
Phase 3 |
Novartis Pharmaceuticals has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape) |
Resource links provided by NLM:
Genetics Home Reference related topics:
Cushing disease
Drug Information available for:
Pasireotide
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Proportion of patients having a drug-related adverse event that is recorded as grade 3 or 4 or as a serious adverse event [ Time Frame: Week 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of patients with mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) [ Time Frame: Baseline, week 12, 24 and 48 ] [ Designated as safety issue: No ]
- Proportion of patients achieving a reduction of mean UFC ≥ 50% [ Time Frame: Baseline, week 12, 24 and 48 ] [ Designated as safety issue: No ]
- Change in Cushing's disease clinical signs and symptoms [ Time Frame: Baseline, week 12, 24 and 48 ] [ Designated as safety issue: No ]
- Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) scores [ Time Frame: Baseline, week 12, 24 and 48 ] [ Designated as safety issue: No ]
- Change in GH and IGF-I values [ Time Frame: Baseline, week 12, 24 and 48 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pasireotide sub-cutaneous formulation
Pasireotide will be administered twice a day until pasireotide is approved and reimbursed for commercial use in each respective country or until 31DEC13, whichever comes first
|
Drug: Pasireotide sub-cutaneous formulation
Pasireotide will be administered twice a day until pasireotide is approved and reimbursed for commercial use in each respective country or until 31DEC13, whichever comes first
Other Name: SOM230 sub-cutaneous formulation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
Patients with confirmed diagnosis of Cushing's disease as evidenced by
- mean urinary free cortisol of three 24-hour urine samples collected during the 2-week screening period above the upper limit of the laboratory normal range
- morning plasma adrenocorticotropic hormone (ACTH) within the normal or above normal range
- either Magnetic Resonance Imaging (MRI) confirmation of pituitary adenoma (greater than or equal to 0.6 cm), or inferior petrosal sinus gradient >3 after corticotrophin-releasing hormone (CRH) stimulation for those patients with a microadenoma less than 0.6 cm, or for patients who have had prior pituitary surgery, histopathology confirming an ACTH staining adenoma.
- Patients with de novo Cushing's disease must not be considered as candidates for pituitary surgery (i.e. poor surgical candidates, surgically unapproachable tumors, patients with no visible pituitary tumor, patients who refuse to have surgical treatment)
- Karnofsky performance status >60 (i.e. requires occasional assistance, but is able to care for most of his personal needs)
Exclusion criteria:
- Radiotherapy of the pituitary <4 weeks before screening or patient who has not recovered from side effects
- Patients with compression of the optic chiasm causing acute clinically significant visual field defect
- Patients with Cushing's syndrome due to ectopic ACTH secretion
- Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
- Patients who have undergone major surgery within 1 month prior to screening
- Patients with symptomatic cholelithiasis
- Patients who have clinically significant impairment in cardiovascular function or are at risk thereof.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582061
Hide Study Locations
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Hide Study LocationsLocations
| United States, Alabama | |
| University of Alabama at Birmingham | Not yet recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact +1 205 934 2130 | |
| Principal Investigator: Tom Brooks Vaughan | |
| United States, Arizona | |
| Panda Medical Associates/Clin TriCo | Recruiting |
| Peoria, Arizona, United States, 85381 | |
| Contact: Cyndi Sepico cyndi@clintrico.com | |
| Principal Investigator: Chioma Iweha | |
| St. Joseph's Hospital & Medical Center St Joes | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact: Emily Khoury 602-406-3614 emily.khoury@chw.edu | |
| Principal Investigator: Laura Knecht | |
| United States, Arkansas | |
| University of Arkanasas for Medical Sciences | Withdrawn |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Cedars Sinai Medical Center | Withdrawn |
| Los Angeles, California, United States, 90048 | |
| University of California at Los Angeles UCLA Tiverton | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Brittany Sumerel 310-825-5874 bsumerel@mednet.ucla.edu | |
| Principal Investigator: Anthony P. Heaney | |
| San Diego Endocrine & Medical Clinic | Recruiting |
| San Diego, California, United States, 92108 | |
| Contact 619-220-7990 | |
| Principal Investigator: Georges M. Argoud | |
| University of California San Francisco | Withdrawn |
| San Francisco, California, United States, 94143-0326 | |
| John Wayne Cancer Institute | Not yet recruiting |
| Santa Monica, California, United States, 90404 | |
| Contact 310-829-8858 | |
| Principal Investigator: Daniel F. Kelly | |
| Stanford Cancer Center | Withdrawn |
| Stanford, California, United States, 94305 | |
| LA Biomedical Research at Harbor UCLA Medical Center | Recruiting |
| Torrance, California, United States, 90502 | |
| Contact 310-222-4060 | |
| Principal Investigator: Ronald Swerdloff | |
| United States, Colorado | |
| University of Colorado | Withdrawn |
| Aurora, Colorado, United States, 80045 | |
| United States, District of Columbia | |
| George Washington University Medical Center | Not yet recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact 202-741-2293 | |
| Principal Investigator: Zachary Litvak | |
| United States, Georgia | |
| Emory University School of Medicine | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact 404-727-5725 | |
| Principal Investigator: Adriana Ioachimescu | |
| United States, Illinois | |
| Northwestern University | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact 312-908-1299 | |
| Principal Investigator: Mark Molitch | |
| John H. Stroger, K., Hospital of Cook County | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact 312-864-0539 | |
| Principal Investigator: Leon Fogelfeld | |
| United States, Maryland | |
| U of Maryland Medical Center | Not yet recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact 410-328-0303 | |
| Principal Investigator: Kashif Munir | |
| United States, Massachusetts | |
| Tufts Medical Center | Not yet recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact 617-636-0710 | |
| Principal Investigator: Ronald M. Lechan | |
| Tufts Medical Center | Withdrawn |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| University of Michigan Medical Center | Withdrawn |
| Ann Arbor, Michigan, United States, 48109-0922 | |
| Wayne State University | Withdrawn |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Washington University | Not yet recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact 341-362-3181 | |
| Principal Investigator: Julie Silverstein | |
| United States, Nebraska | |
| Diabetes and Endocrinology Associates, PC | Recruiting |
| Omaha, Nebraska, United States, 68131 | |
| Contact 402-561-2665 | |
| Principal Investigator: Claire H. Baker | |
| U of Nebraska Medical Center | Not yet recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact 402-559-4341 | |
| Principal Investigator: Andjela Drincic | |
| United States, New Mexico | |
| University of New Mexico Hospital UNM | Not yet recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Lisa Toelle 505-272-1663 ljtoelle@salud.unm.edu | |
| Principal Investigator: Kathleen Colleran | |
| United States, New York | |
| Mount Sinai School of Medicine | Not yet recruiting |
| New York, New York, United States, 10029 | |
| Contact 212-659-8833 | |
| Principal Investigator: Eliza B. Geer | |
| University of Rochester Medical Center | Withdrawn |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Withdrawn |
| Cleveland, Ohio, United States, 44195 | |
| Toledo Clinic | Not yet recruiting |
| Toledo, Ohio, United States, 43623 | |
| Contact 419-479-5560 | |
| Principal Investigator: Ian Elliot | |
| United States, Oregon | |
| Oregon Health & Science University OHSU 5 | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Sarah Colton 503-494-9546 colton@ohsu.edu | |
| Principal Investigator: Maria Fleseriu | |
| United States, Pennsylvania | |
| Temple University | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact 215-707-5477 | |
| Principal Investigator: Elias Siraj | |
| University of Pennsylvania Medical Center Univ Penn | Recruiting |
| Philadephia, Pennsylvania, United States, 19104 | |
| Contact: Invest Drug 215-898-5664 rockwelk@mail.med.upenn.edu | |
| Principal Investigator: Peter J. Snyder | |
| Allegheny Endocrinology Associates | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact 412-359-5143 | |
| Principal Investigator: Murray B. Gordon | |
| United States, Rhode Island | |
| Rhode Island Hospital | Not yet recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact 401-444-5901 | |
| Principal Investigator: Geetha Gopalakrishnan | |
| United States, South Carolina | |
| Medical University of South Carolina | Withdrawn |
| Charleston, South Carolina, United States, 29406 | |
| United States, Tennessee | |
| Mid South Endocrine Associates | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact 615-329-5029 | |
| Principal Investigator: Terri Jerkins | |
| Vanderbilt University Medical Center | Not yet recruiting |
| Nashville, Tennessee, United States, 37212 | |
| Contact 615-936-0067 | |
| Principal Investigator: Andrea Utz | |
| United States, Texas | |
| University of Texas Southwestern Medical Center UT southwest | Withdrawn |
| Dallas, Texas, United States, 75390-8527 | |
| Baylor College of Medicine | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact 713-793-7664 | |
| Principal Investigator: Susan L. Samson | |
| United States, Washington | |
| Swedish Cancer Institute Swedish Cancer Institute (SC) | Not yet recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Becky Wood 206-320-7115 becky.wood@swedish.org | |
| Principal Investigator: Frances Broyles | |
| Brazil | |
| Novartis Investigative Site | Recruiting |
| Fortaleza, CE, Brazil, 60155-290 | |
| Novartis Investigative Site | Recruiting |
| Joinville, SC, Brazil, 89201260 | |
| Novartis Investigative Site | Withdrawn |
| São Paulo, SP, Brazil, 01401-901 | |
| Novartis Investigative Site | Recruiting |
| São Paulo, SP, Brazil, 05403-000 | |
| Novartis Investigative Site | Recruiting |
| São Paulo, SP, Brazil, 04029-000 | |
| Czech Republic | |
| Novartis Investigative Site | Recruiting |
| Prague 2, Czech Republic, 120 00 | |
| Egypt | |
| Novartis Investigative Site | Not yet recruiting |
| Alexandria, Egypt | |
| Novartis Investigative Site | Not yet recruiting |
| Mansoura, Egypt | |
| Germany | |
| Novartis Investigative Site | Completed |
| Aachen, Germany, 52074 | |
| Novartis Investigative Site | Completed |
| Augsburg, Germany, 86150 | |
| Novartis Investigative Site | Withdrawn |
| Berlin, Germany, 12200 | |
| Novartis Investigative Site | Withdrawn |
| Berlin, Germany, 10117 | |
| Novartis Investigative Site | Withdrawn |
| Berlin, Germany, 12159 | |
| Novartis Investigative Site | Terminated |
| Berlin, Germany, 10098 | |
| Novartis Investigative Site | Completed |
| Berlin, Germany, 13353 | |
| Novartis Investigative Site | Withdrawn |
| Bielefeld, Germany, 33604 | |
| Novartis Investigative Site | Withdrawn |
| Dortmund, Germany, 44137 | |
| Novartis Investigative Site | Withdrawn |
| Duesseldorf, Germany, 40225 | |
| Novartis Investigative Site | Completed |
| Erlangen, Germany, 91054 | |
| Novartis Investigative Site | Withdrawn |
| Essen, Germany, 45147 | |
| Novartis Investigative Site | Terminated |
| Frankfurt, Germany, 60329 | |
| Novartis Investigative Site | Completed |
| Frankfurt, Germany, 60590 | |
| Novartis Investigative Site | Active, not recruiting |
| Göttingen, Germany, D-37075 | |
| Novartis Investigative Site | Completed |
| Hamburg, Germany, 22559 | |
| Novartis Investigative Site | Withdrawn |
| Hannover, Germany, 30625 | |
| Novartis Investigative Site | Terminated |
| Heidelberg, Germany, 69120 | |
| Novartis Investigative Site | Withdrawn |
| Kiel, Germany, 24105 | |
| Novartis Investigative Site | Withdrawn |
| Köln, Germany, 50924 | |
| Novartis Investigative Site | Terminated |
| Leipzig, Germany, 04103 | |
| Novartis Investigative Site | Withdrawn |
| Lübeck, Germany, 23538 | |
| Novartis Investigative Site | Completed |
| Mainz, Germany, D-55101 | |
| Novartis Investigative Site | Terminated |
| Marburg, Germany, 35039 | |
| Novartis Investigative Site | Completed |
| Muenchen, Germany, 80804 | |
| Novartis Investigative Site | Withdrawn |
| München, Germany, 80336 | |
| Novartis Investigative Site | Withdrawn |
| Nuernberg, Germany, 90491 | |
| Novartis Investigative Site | Terminated |
| Oldenburg, Germany, 26122 | |
| Novartis Investigative Site | Completed |
| Würzburg, Germany, 97080 | |
| Greece | |
| Novartis Investigative Site | Recruiting |
| Athens, Greece, GR 156 69 | |
| Novartis Investigative Site | Recruiting |
| Athens - GR, Greece, 10676 | |
| Novartis Investigative Site | Recruiting |
| Heraklion/ Crete, Greece, 710 00 | |
| Novartis Investigative Site | Recruiting |
| Larissa, Greece, 41110 | |
| Novartis Investigative Site | Recruiting |
| Pireas, Greece, 18537 | |
| Novartis Investigative Site | Not yet recruiting |
| Thessaloniki, Greece, GR 54635 | |
| Novartis Investigative Site | Not yet recruiting |
| Thessaloniki, Greece, GR 55132 | |
| Novartis Investigative Site | Recruiting |
| Thessaloniki, Greece, GR 546 39 | |
| Korea, Republic of | |
| Novartis Investigative Site | Recruiting |
| Seoul, Korea, Korea, Republic of, 135-710 | |
| Novartis Investigative Site | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Novartis Investigative Site | Recruiting |
| Seoul, Korea, Republic of, 130-702 | |
| Lebanon | |
| Novartis Investigative Site | Recruiting |
| Beirut, Lebanon | |
| Netherlands | |
| Novartis Investigative Site | Completed |
| Enschede, Netherlands, 7513 ER | |
| Novartis Investigative Site | Withdrawn |
| Leiden, Netherlands, 2300 RC | |
| Romania | |
| Novartis Investigative Site | Recruiting |
| Bucharest, Romania, 011461 | |
| Novartis Investigative Site | Recruiting |
| Bucuresti, Romania | |
| Novartis Investigative Site | Recruiting |
| Cluj, Romania, 400006 | |
| Novartis Investigative Site | Recruiting |
| Iasi, Romania, 700106 | |
| Russian Federation | |
| Novartis Investigative Site | Not yet recruiting |
| Krasnoyarsk, Russian Federation, 660022 | |
| Novartis Investigative Site | Not yet recruiting |
| Moscow, Russian Federation, 129110 | |
| Novartis Investigative Site | Not yet recruiting |
| Samara, Russian Federation, 443095 | |
| Spain | |
| Novartis Investigative Site | Recruiting |
| Cordoba, Andalucia, Spain, 14004 | |
| Novartis Investigative Site | Recruiting |
| Sevilla, Andalucia, Spain, 41009 | |
| Novartis Investigative Site | Recruiting |
| Granada, Andalucía, Spain, 18003 | |
| Novartis Investigative Site | Withdrawn |
| Leon, Castilla y Leon, Spain, 24071 | |
| Novartis Investigative Site | Recruiting |
| Badalona, Catalunya, Spain, 08916 | |
| Novartis Investigative Site | Recruiting |
| Valencia, Comunidad Valenciana, Spain, 46014 | |
| Novartis Investigative Site | Recruiting |
| La Coruna, Galicia, Spain, 15006 | |
| Novartis Investigative Site | Recruiting |
| Orense, Galicia, Spain, 32005 | |
| Novartis Investigative Site | Recruiting |
| Palma De Mallorca, Islas Baleares, Spain, 07120 | |
| Novartis Investigative Site | Recruiting |
| Baracaldo, País Vasco, Spain, 48903 | |
| Novartis Investigative Site | Withdrawn |
| Madrid, Spain, 28046 | |
| Novartis Investigative Site | Recruiting |
| Madrid, Spain, 28034 | |
| Novartis Investigative Site | Recruiting |
| Madrid, Spain, 28040 | |
| Novartis Investigative Site | Recruiting |
| Pontevedra, Spain, 36071 | |
| Novartis Investigative Site | Recruiting |
| Valencia, Spain, 46026 | |
| Thailand | |
| Novartis Investigative Site | Recruiting |
| Bangkok, Thailand, 10330 | |
| Novartis Investigative Site | Recruiting |
| Songkla, Thailand, 90110 | |
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: | NCT01582061 History of Changes |
| Other Study ID Numbers: | CSOM230B2406 |
| Study First Received: | April 12, 2012 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Food and Drug Administration Brazil: Ethics Committee Brazil: Ministry of Health Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control Egypt: Institutional Review Board Germany: Ethics Commission Germany: Ministry of Health Greece: Ethics Committee Greece: Ministry of Health and Welfare Lebanon: Institutional Review Board Netherlands: Independent Ethics Committee Netherlands: Medicines Evaluation Board (MEB) Romania: National Medicines Agency Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation South Korea: Institutional Review Board South Korea: Korea Food and Drug Administration (KFDA) Spain: Ethics Committee Spain: Ministry of Health Thailand: Ethical Committee Thailand: Food and Drug Administration |
Keywords provided by Novartis:
|
Cushing's disease Hormone disorder Cortisol Adrenocorticotropic hormone Pituitary tumor |
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 Adrenocorticotropic Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013