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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


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Nelson Syndrome

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Trial Information

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


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

- Negative pregnancy test where applicable

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.

- Patients with symptomatic cholelithiasis

- 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 sixmonth period prior to Visit 1, or who plan
to take an investigational

- 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 noncompliance 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Serum ACTH levels in patients with Nelson's syndrome.

Outcome Description:

Early morning plasma ACTH sampled at 0, 1, 2, and 3 hours after morning hydrocortisone (HC) during 4 weeks of pasireotide 1200ug/day compared with levels at these respective time points found at baseline, and after chronic depot pasireotide 60mg i.m every 28 days: Complete success: Fall in pre-HC plasma ACTH > 400ng/l, or 120 minutes after HC >200ng/l Partial success: Fall in pre-HC plasma ACTH < 399ng/l >200ng/l, or 120 minutes after HC <199ng/l >100ng/l No success: Fall in pre-HC plasma ACTH < 199ng/l, or 120 minutes after HC <99ng/l

Safety Issue:

No

Principal Investigator

John Newell-Price

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sheffield Teaching Hospitals NHS Foundation Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

STH15164

NCT ID:

NCT01617733

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Nelson Syndrome
  • Nelson Syndrome

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