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

Study Description

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Brief Summary:

This study provided access to pasireotide sc in patients with Cushing's disease.and provided additional information for safety and efficacy of pasireotide s.c.

Condition or disease	Intervention/treatment	Phase
Cushing's Disease	Drug: Pasireotide sub-cutaneous	Phase 3

Detailed Description:

Purpose of this study was to give access to pasireotide sc for patients with Cushing's disease as no medical treatment for Cushing's disease was approved at the time of the study initiation. The study population consisted of patients with persistent or recurrent Cushing's disease or patients with de novo Cushing's disease that were not considered candidates for pituitary surgery (poor surgery candidates, surgically unapproachable tumor, patients with no visible pituitary tumor, patients who refused surgery). A confirmed Cushing's disease diagnosis was required.

Study Design

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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

Arms and Interventions

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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	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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. Proportion of patients with mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN) [ Time Frame: Baseline, week 12, 24 and 48 ]
2. Proportion of patients achieving a reduction of mean UFC ≥ 50% [ Time Frame: Baseline, week 12, 24 and 48 ]
3. Change in Cushing's disease clinical signs and symptoms [ Time Frame: Baseline, week 12, 24 and 48 ]
4. 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 ]
5. Change in GH and IGF-I values [ Time Frame: Baseline, week 12, 24 and 48 ]

Eligibility Criteria

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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

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  Show 65 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01582061 History of Changes
Other Study ID Numbers:	CSOM230B2406
First Posted:	April 20, 2012
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