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

Primary Purpose

Cushing's Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SOM230 s.c.
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cushing's Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cedars-Sinai Pituitary Center
  • Massachusetts General Hospital NE Unit
  • Oregon Health & Science University
  • University of Pennsylvania
  • Midwest Endocrinology Associates

Outcomes

Primary Outcome Measures

Urinary Free Cortisol after 15 days of treatment

Secondary Outcome Measures

Serum cortisol
ACTH
Clinical manifestations
Pharmacokinetics
Safety
Tolerability
Development of biomarkers

Full Information

First Posted
July 30, 2004
Last Updated
November 3, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00088608
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SOM230 s.c.
Primary Outcome Measure Information:
Title
Urinary Free Cortisol after 15 days of treatment
Secondary Outcome Measure Information:
Title
Serum cortisol
Title
ACTH
Title
Clinical manifestations
Title
Pharmacokinetics
Title
Safety
Title
Tolerability
Title
Development of biomarkers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Pituitary Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Massachusetts General Hospital NE Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Midwest Endocrinology Associates
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18957506
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.
Results Reference
result
PubMed Identifier
24482099
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.
Results Reference
derived

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

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