We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582061
First Posted: April 20, 2012
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]

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 ]
  • Proportion of patients achieving a reduction of mean UFC ≥ 50% [ Time Frame: Baseline, week 12, 24 and 48 ]
  • Change in Cushing's disease clinical signs and symptoms [ Time Frame: Baseline, week 12, 24 and 48 ]
  • 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 ]
  • Change in GH and IGF-I values [ Time Frame: Baseline, week 12, 24 and 48 ]

Enrollment: 104
Actual Study Start Date: August 16, 2011
Study Completion Date: January 26, 2017
Primary Completion Date: January 26, 2017 (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 31DEC15, 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 31DEC15, whichever comes first
Other Name: SOM230 sub-cutaneous formulation

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

  Contacts and Locations
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): NCT01582061


  Show 65 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01582061     History of Changes
Other Study ID Numbers: CSOM230B2406
First Submitted: April 12, 2012
First Posted: April 20, 2012
Last Update Posted: December 5, 2017
Last Verified: December 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cushing's disease
Hormone disorder
Cortisol
Adrenocorticotropic hormone
Pituitary tumor

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