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An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cushing's Disease

Thank you

Trial Information

An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape)

Inclusion Criteria


Inclusion criteria:

1. 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.

2. 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)

3. Karnofsky performance status >60 (i.e. requires occasional assistance, but is able to
care for most of his personal needs)

Exclusion criteria:

1. Radiotherapy of the pituitary <4 weeks before screening or patient who has not
recovered from side effects

2. Patients with compression of the optic chiasm causing acute clinically significant
visual field defect

3. Patients with Cushing's syndrome due to ectopic ACTH secretion

4. Patients with hypercortisolism secondary to adrenal tumors or nodular (primary)
bilateral adrenal hyperplasia

5. Patients who have undergone major surgery within 1 month prior to screening

6. Patients with symptomatic cholelithiasis

7. Patients who have clinically significant impairment in cardiovascular function or are
at risk thereof.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients having a drug-related adverse event that is recorded as grade 3 or 4 or as a serious adverse event

Outcome Time Frame:

Week 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, 48

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSOM230B2406

NCT ID:

NCT01582061

Start Date:

August 2011

Completion Date:

January 2014

Related Keywords:

  • Cushing's Disease
  • Cushing's disease
  • Hormone disorder
  • Cortisol
  • Adrenocorticotropic hormone
  • Pituitary tumor
  • Cushing Syndrome
  • Pituitary ACTH Hypersecretion

Name

Location

Baylor College of MedicineHouston, Texas  77030
Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Cleveland Clinic FoundationCleveland, Ohio  44195
George Washington University Medical CenterWashington, District of Columbia  20037
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Mount Sinai School of MedicineNew York, New York  10029
Rhode Island HospitalProvidence, Rhode Island  02903
John Wayne Cancer InstituteSanta Monica, California  90404
University of Rochester Medical CenterRochester, New York  14642
Emory University School of MedicineAtlanta, Georgia  30322
University of ColoradoDenver, Colorado  80217
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Stanford Cancer CenterStanford, California  94305-5824
Temple UniversityPhiladelphia, Pennsylvania  19140
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
University of California San FranciscoSan Francisco, California  941104206
Northwestern UniversityChicago, Illinois  60611
Wayne State UniversityDetroit, Michigan  48202
Toledo ClinicOregon, Ohio  43616
Washington UniversitySt. Louis, Missouri  63110
Tufts Medical CenterBoston, Massachusetts  02111
U of Maryland Medical CenterBaltimore, Maryland  21201
Allegheny Endocrinology AssociatesPittsburgh, Pennsylvania  15212
University of Texas Southwestern Medical Center UT southwestDallas, Texas  75390-8527
Panda Medical Associates/Clin TriCoPeoria, Arizona  85381
St. Joseph's Hospital & Medical Center St JoesPhoenix, Arizona  85013
Diabetes and Endocrinology Associates, PCOmaha, Nebraska  68131
University of New Mexico Hospital UNMAlbuquerque, New Mexico  87106
Oregon Health & Science University OHSU 5Portland, Oregon  97239
University of Pennsylvania Medical Center Univ PennPhiladephia, Pennsylvania  19104
Mid South Endocrine AssociatesNashville, Tennessee  37203
Swedish Cancer Institute Swedish Cancer Institute (SC)Seattle, Washington  98104
University of California at Los Angeles UCLA TivertonLos Angeles, California  90095
University of Arkanasas for Medical SciencesLittle Rock, Arkansas  72205
San Diego Endocrine & Medical ClinicSan Diego, California  92108
LA Biomedical Research at Harbor UCLA Medical CenterTorrance, California  90502
John H. Stroger, K., Hospital of Cook CountyChicago, Illinois  60612
U of Nebraska Medical CenterOmaha, Nebraska  68198