A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease

Cushing's Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088608
• Other study ID #: CSOM230B2208
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2004
• Last updated: November 3, 2016
• Start date: April 2004

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Cushing Syndrome
• Cushing's Syndrome
• Pituitary ACTH Hypersecretion

Intervention

Drug:
• SOM230 s.c.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital NE Unit	Boston	Massachusetts
United States	Cedars-Sinai Pituitary Center	Los Angeles	California
United States	Midwest Endocrinology Associates	Milwaukee	Wisconsin
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Free Cortisol after 15 days of treatment
Secondary	Serum cortisol
Secondary	ACTH
Secondary	Clinical manifestations
Secondary	Pharmacokinetics
Secondary	Safety
Secondary	Tolerability
Secondary	Development of biomarkers

External Links

•   Novartis Clinical Trial Results on CSOM230B2208