Treatment of Cushing's disease MedDRA version: 14.1 Level: PT Classification code 10035109 Term: Pituitary-dependent Cushing's syndrome System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Name: NA
Product Code: SOM230B
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE
CAS Number: 396091-77-3
Current Sponsor code: SOM230B
Concentration unit: µg microgr
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients have completed the 15 days of SOM230 treatment in [study CSOM230B2208]. • The patient achieved normalization of 24-hour urinary free cortisol, • If the patient did not achieve normalization of 24 -hour urinary free cortisol, but the investigator believes the patient is getting significant clinical benefits from treatment with SOM230, the patient may be continued on therapy after approval by Novartis. • The patient did not experience any unacceptable adverse events of tolerability issues during the original 15 day treatment. • 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: 0 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: • Patients who have developed poorly controlled diabetes mellitus as indicated by ketoacidosis or HgbA1C > 10 since starting [study CSOM230B2208] • Patients with persistent ALT/AST or alkaline phosphatase levels more than 2.5X ULN, serum creatinine > 2.0 X ULN, serum bilirubin > 2 X ULN • Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits), WBC <3.0x109/L; Hgb <12.0g/dL for females, Hgb <13.0g/dL for males; PLT<100x109/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the long-term efficacy of SOM230 in patients with Cushing’s disease;Secondary Objective: • To assess the long-term safety and tolerability of SOM230 in patients with Cushing’s disease; • To monitor trough plasma concentrations of SOM230 after chronic dosing; • To investigate gene-expression and protein changes in blood and urine for biomarker development.;Primary end point(s): - Normalisation of urinary free cortisol levels after 6 months -Normalisation of plasma ACTH and serum cortisol levels | — |
Countries
Italy, United Kingdom
Contacts
Public ContactDrug Regulatory Affairs
NOVARTIS FARMA
Outcome results
None listed