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

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: No masking 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

Genetic and Rare Diseases Information Center resources: ACTH-secreting Pituitary Adenoma

U.S. FDA Resources

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	April 12, 2012
Last Updated:	April 7, 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

ClinicalTrials.gov processed this record on June 26, 2017