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• Register: EUCTR
• Last refreshed on: 23 March 2015
• Main ID: EUCTR2006-004111-22-IT
• Date of registration: 05/01/2007
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: //
• Scientific title: A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230)s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing`s disease
• Date of first enrolment: 23/11/2006
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004111-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Other specify the comparator: - same IMP used at different dosage Number of treatment arms in the trial: 2

Countries of recruitment

Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Portugal, Spain, United Kingdom

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: NOVARTIS FARMA

• Name: Drug Regulatory Affairs
• Affiliation: NOVARTIS FARMA

Key inclusion & exclusion criteria

Inclusion criteria:
`Male or female patients aged 18 years or greater `Patients with confirmed diagnosis of ACTH-dependent Cushing`s disease, as evidenced by (1) mean UFC from two 24-hour urinary collections at least two times the upper limit of the laboratory normal range collected within 2 weeks; (2) morning plasma ACTH within the normal or above normal range; (3) either MRI confirmation of pituitary macroadenoma (greater than or equal to 1 cm) or inferior petrosal sinus gradient >3 after corticotrophin-releasing hormone (CRH) or for patients who have had prior pituitary surgery, documentation confirming an ACTH staining adenoma (an MRI is also required). This diagnosis must be verified within 2 months prior to study entry `Patients with de novo Cushing`s disease can be included only if they are not considered candidates for pituitary surgery (poor surgery candidates, surgically unapproachable tumors, patients who refuse to have surgical treatment) `Karnofsky performance status `?¥60 (i.e. requires occasional assistance, but is able to care for most of this personal needs) `For patients on medical treatment for Cushing`s disease the followingassessments are performed `Inhibitors of steroidogenesis - ketoconazole, metyrapone, rosiglitazone: 1 week `Dopamine agonists - bromocriptine, cabergoline: 4 weeks `Octreotide LAR and Lanreotide autogel: 8 weeks `Lanreotide SR: 4 weeks `Octreotide - immediate release formulation: 1 week
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 received pituitary irradiation, as the onset time of the radiation effects can not be determined `Patients who have been treated with mitotane during the last 6 months `Patients with compression of the optic chiasm causing any visual field defect, in order to exclude patients with a tumor causing chiasma compression requiring surgery `Patients with Cushing`s syndrome due to ectopic ACTH secretion `Patients with hypercortisolism secondary to adrenal tumors or Nodular (primary) bilateral adrenal hyperplasia `Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1) `Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA) `Patients who are not biochemically euthyroid `Patients who have undergone major surgery within 1 month `Patients with symptomatic cholelithiasis `Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by HbA1C >8% `Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits) `Patients receiving anticoagulants that affect PT or PTT `Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, symptomatic bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function `Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST more than 2 X ULN, serum creatinine >2.0 X ULN, serum bilirubin >2.0 X ULN, serum albumin >1.5 X ULN


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

Health Condition(s) or Problem(s) studied

de novo or persistent/recurrent Cushing disease
MedDRA version: 14.1 Level: PT Classification code 10011652 Term: Cushing's syndrome System Organ Class: 10014698 - Endocrine disorders

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

Intervention(s)

Product Name: pasireotide
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-

Product Name: pasireotide
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: 600-

Product Name: pasireotide
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: 300-

Primary Outcome(s)

Primary end point(s): Proportion of patients in each independent treatment arm with `?¤1.5 X ULN and `?¥50% reduction in UFC from baseline at 6 months

Secondary Objective: `To assess censor-adjusted response `To assess pooled dose response `To assess median UFC response `To assess time to response `To assess the response by dose group `To assess normalization of UFC at 6 months `To assess the effect of pasireotide s.c. on plasma ACTH and serum cortisol `To assess improvement in clinical signs: blood pressure, body mass index, waist circumference and weight reduction `To assess improvement in clinical symptoms of Cushing`s disease: depression, facial rubor, supraclavicular and dorsal fat pads, hirsutism, striae, muscle strength, bone density and body composition `To assess the effect of pasireotide s.c. on Quality of Life `To determine the pharmacokinetics of pasireotide after s.c. b.i.d. administration

Main Objective: To assess the efficacy in terms of response to pasireotide 600 µg s.c. b.i.d. and 900 µg s.c. b.i.d. independently in patients with Cushing`s disease as measured by UFC `?¤1.5 X ULN and `?¥50% reduction of urinary free cortisol (UFC) from baseline after 6 months of treatment

Secondary ID(s)

CSOM230B2305

2006-004111-22-DK

Source(s) of Monetary Support

Novartis Pharma Services AG