Nelson's Syndrome
Conditions
Interventions
Product Name: Pasireotide Long acting release (LAR)
Pharmaceutical Form: Injection*
INN or Proposed INN: Pasireotide
Other descriptive name: Pasieotide
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does pasireotide lower on the level of level of the circulating hormone ACTH in patients with Nelson's Syndrome?;Secondary Objective: The effect of chronic pasireotide therapy on tumour volume in patients with Nelson's Syndrome. The effect of acute and chronic pasireotide therapy on skin pigmentation in patients with Nelson's Syndrome. The safety and tolerability of acute and chronic pasireotide therapy. Somatostatin receptor expression screening in vitro using the patients historical paraffin embedded tumour specimens. ;Primary end point(s): Phase 1 Primary end point: 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: 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 200ng/l, or 120 minutes after HC 100ng/l No success: Fall in pre-HC plasma ACTH 400ng/l, or 120 minutes after HC >200ng/l Partial success: Fall in pre-HC plasma ACTH 200ng/l, or 120 minutes after HC 100ng/l No success: Fall in pre-HC plasma ACTH < 199ng/l, or 120 minutes after HC <99ng/l | — |
Countries
United Kingdom
Outcome results
None listed