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• Register: EUCTR
• Last refreshed on: 14 October 2013
• Main ID: EUCTR2004-002407-32-IT
• Date of registration: 16/09/2004
• Prospective Registration: Yes
• Primary sponsor: NOVARTIS FARMA
• Public title: \\
• Scientific title: Extension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's disease
• Date of first enrolment: 21/10/2004
• Target sample size: 26
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002407-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Italy, United Kingdom

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: NOVARTIS FARMA

• Name: Drug Regulatory Affairs
• Affiliation: NOVARTIS FARMA

Key inclusion & exclusion 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:
• 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

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

Intervention(s)

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 microgram(s)
Concentration number: 900-

Primary Outcome(s)

Primary end point(s): - Normalisation of urinary free cortisol levels after 6 months -Normalisation of plasma ACTH and serum cortisol levels

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.

Secondary ID(s)

CSOM230B2208E1

Source(s) of Monetary Support

Novartis Pharma Services AG