An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.
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ClinicalTrials.gov Identifier: NCT01582061 |
Recruitment Status
:
Completed
First Posted
: April 20, 2012
Last Update Posted
: January 16, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cushing's Disease | Drug: Pasireotide sub-cutaneous | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Non-Randomized |
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). |
Actual Study Start Date : | August 16, 2011 |
Actual Primary Completion Date : | January 26, 2017 |
Actual Study Completion Date : | January 26, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Pasireotide 600 μg
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients
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Drug: Pasireotide sub-cutaneous
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg, 600 μg, or 300 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg and 600 μg for glucose impaired metabolism patients
Other Name: SOM230 sub-cutaneous
|
Experimental: Pasireotide 900 μg
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg
|
Drug: Pasireotide sub-cutaneous
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg, 600 μg, or 300 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg and 600 μg for glucose impaired metabolism patients
Other Name: SOM230 sub-cutaneous
|
- 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 ]
- 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 ]

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

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

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01582061 History of Changes |
Other Study ID Numbers: |
CSOM230B2406 |
First Posted: | April 20, 2012 Key Record Dates |
Last Update Posted: | January 16, 2018 |
Last Verified: | January 2018 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cushing's disease Hormone disorder Cortisol Adrenocorticotropic hormone |
Pituitary tumor SOM230 adult |
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 Somatostatin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |