Clinical trial NCT00088608: A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease
Official title: A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cushing's Syndrome
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-08-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study treatment period is 15 days in length and includes patients with pituitary Cushing's disease who are candidates for surgical intervention as well as and patients who have recurrent Cushing's post operatively.


Eligibility criteria: Inclusion Criteria:

* Patients with pituitary Cushing's disease within the two months prior to study entry
* Patients for whom written informed consent to participate in the study has been obtained
* Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the study, and for one month after the study has ended

Exclusion Criteria:

* Female patients who are pregnant or lactating
* Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
* Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or HgbA1C \> 10
* Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or history of acute MI less than one year prior to the study entry or clinically significant impairment in cardiovascular function (e.g. blood pressure of 190/100mmHg or greater)
* Patients with chronic liver disease
* Patients with clotting disorders or abnormal blood counts
* History of immuno-compromise, including a positive HIV test result
* Patients with active gall bladder disease
* Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
* Patients with active malignant disease (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)

Primary outcomes:
measure: Urinary Free Cortisol after 15 days of treatment
Secondary outcomes:
measure: Serum cortisol
measure: ACTH
measure: Clinical manifestations
measure: Pharmacokinetics
measure: Safety
measure: Tolerability
measure: Development of biomarkers
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Pituitary Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital NE Unit
state: Massachusetts
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Milwaukee
country: United States
facility: Midwest Endocrinology Associates
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Boscaro M, Ludlam WH, Atkinson B, Glusman JE, Petersenn S, Reincke M, Snyder P, Tabarin A, Biller BM, Findling J, Melmed S, Darby CH, Hu K, Wang Y, Freda PU, Grossman AB, Frohman LA, Bertherat J. Treatment of pituitary-dependent Cushing's disease with the multireceptor ligand somatostatin analog pasireotide (SOM230): a multicenter, phase II trial. J Clin Endocrinol Metab. 2009 Jan;94(1):115-22. doi: 10.1210/jc.2008-1008. Epub 2008 Oct 28.
citation: Trementino L, Cardinaletti M, Concettoni C, Marcelli G, Polenta B, Spinello M, Boscaro M, Arnaldi G. Salivary cortisol is a useful tool to assess the early response to pasireotide in patients with Cushing's disease. Pituitary. 2015 Feb;18(1):60-7. doi: 10.1007/s11102-014-0557-x.