Extension to a multicenter, randomized, crossover, open label, dose finding study to compare the safety, efficacy and PK/PD relationship of multiple doses of SOM230 (200, 400 and 600 µg b.i.d.) and doses of open label Sandostatin (100 µg t.i.d.) in acromegalic patients

• Conditions: Acromegaly is a rare, serious condition characterized by chronic hypersecretion of GH (growth hormone) caused in over 95% of patients by a GH-secreting pituitary adenoma. Clinical manifestations are due to excess GH and elevated IGF-I concentrations and/or the central pressure effects of the tumor mass. Clinical features comprise structural and functional changes occurring in practically all organs. Cardiovascular disease is the main reason for morbidity and increased mortality of patients.; MedDRA version: 7.0Level: LLTClassification code 10000599

• Registration Number: EUCTR2004-002849-12-GB
• Lead Sponsor: ovartis Pharmaceuticals UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-07
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

•Male or female patients aged between 18 and 80 years.
•Patients must have completed all four treatment regimens in [study 2201], and achieved biochemical control (as defined above) after at least one month of SOM230 administration at any of the three doses
•The patient did not experience any unacceptable adverse events or tolerability issues during the original SOM230 treatments.
•Patients who entered the original protocol with diabetes mellitus may be included, but it is recommended that the glucose levels and treatment for diabetes are monitored throughout the trial. If a patient developed diabetes or glucose intolerance during [study 2201] that did not resolve following cessation of treatment with SOM230, they are not eligible for the extension protocol.
•Karnofsky Performance Status = 60
•Written informed consent to participate in the extension 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 extension study, and for one month after the study has ended

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Compression of the optic chiasm causing any visual field defect.
•Patient required a surgical intervention for relief of any sign or symptom associated with tumor compression.
•Congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or acute myocardial infarction .
•Symptomatic cholelithiasis.
•Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, or alkaline phosphatase levels more than twice the upper limit of normal; or direct bilirubin more than 10% of the upper limit of normal.
•A hypersensitivity to SOM230.
•Abnormal clinical laboratory values considered by the Investigator or the Sponsor’s Medical Monitor to be clinically significant and which could affect the interpretation of the study results.
•Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable and highly effective method for birth control. If oral contraception is used, the patient must have been practicing this method for at least two months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for one month after the study has ended.
•Patients who have developed glucose intolerance or diabetes mellitus that does not resolve once SOM230 treatment is stopped.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To assess the long-term safety and efficacy of SOM230 in patients with acromegaly;Secondary Objective: •To assess PK exposure of SOM230 in patients with acromegaly<br>•To investigate gene-expression and protein changes in blood and urine for biomarker development<br>;Primary end point(s):