An Open Label, Longitudinal Study of the Effects of Subcutaneous Acute and Chronic Pasireotide (SOM230) Therapy on Adrenocorticotrophic Hormone and Tumour Volume in Patients with Nelson's Syndrome. - Pasireotide Therapy in Patients with Nelson's Syndrome Version 1.1

Phase 1

• Conditions: elson's Syndrome

• Registration Number: EUCTR2009-014457-33-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-07
• Study Completion: 2014-05-21
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Inclusion criteria
To be verified at Visit one and confirmed at Visit two.

•Male or female patients aged 18-80 years
•Signs and symptoms consistent with Nelson’s Syndrome.
•Biochemistry consistent with Nelsons syndrome: failure to suppress plasma ACTH to less than 200 pg/ml at 2 hours following morning dose of hydrocortisone.

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

•Received any prior or current treatment with a pasireotide or other somatostatin analogue.
•Requires surgery for recent significant deterioration in visual fields or other neurological signs related to tumour mass.
•Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, alkaline phosphates 2X> upper limit of normal, or total bilirubin 1.5X> upper limit of normal.
•Abnormal clinical laboratory values considered by the Investigator to be clinically significant and which could affect the interpretation of the study results
•QTcF interval as measured by ECG >480msecs
•Any current or prior medical condition that may, in the opinion of the Investigator, interfere with the conduct of the study or evaluation of the results.
•Female patients who are pregnant or lactating, or of childbearing potential and not practising a medically acceptable method of birth control. Medically acceptable methods include including the oral contraceptive pill, intrauterine devices, mechanical methods (e.g. vaginal diaphragm, vaginal sponge, or condom with permicidal jelly).
•History of alcohol or drug abuse in the six-month period prior to Visit 1, or who plan to take an investigational drug for another study during this study.
•History of non-compliance to medical regimes or who are considered potentially unreliable.
•Pituitary radiotherapy within the last 1 year prior to study entry.
•Unable to complete the entire study for any reason.

Study & Design

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