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

Not Applicable

Conditions: -E220 Acromegaly and pituitary gigantism
Acromegaly and pituitary gigantism
E220

Registration Number: PER-171-08

Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 0

Inclusion Criteria

• Men or women 18 years of age or older
• Patients with a confirmed diagnosis of AGTH-dependent Gushing disease, evidenced by (1) average GLU of 2 urine collections of 24 hours at least 2 times the normal upper limit of the laboratory range, collected within 2 weeks; (2) Morning plasma ACTH within or above the normal range; (3) confirmation of pituitary macroadenoma by NMR (greater than or equal to 1 cm) or gradient of the inferior petrosal sinus> 3 after corticotrophin releasing hormone (CRH) or for patients who have undergone prior pituitary surgery, documentation confirming an adenoma with ACTH staining (MRI is also required). This diagnosis must be verified within 2 months prior to admission to the study.
• Patients with de novo Cushing disease can be included only if they are not considered candidates for pituitary surgery (candidates not suitable for surgery, surgically unapproachable tumors, patients who refuse surgical treatment)
• Karnofsky performance status> 60 (ie, it requires occasional assistance, but is able to take care of most of your personal needs)
• For patients undergoing medical treatment for Cushing´s disease, the following drug elimination periods must be completed before performing the baseline efficacy evaluations
• Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment should be monitored thoroughly throughout the entire trial and adjust the treatment as needed.

Exclusion Criteria

• Patients who have received pituitary radiation, since the beginning of the radiation effect cannot be determined
• Patients who have been treated with mitotane during the last 6 months
• Patients with compression of the optic chiasma causing some visual field defect, in order to exclude patients with tumors that cause compression of the optic chiasma that require surgery
• Patients with Cushing syndrome due to ectopic ACTH secretion
• Patients with hypercortisolism secondary to adrenal tumors or bilateral nodular adrenal hyperplasia (primary)
• Patients who have a hereditary syndrome known as the cause of hormonal hypersecretion (for example Carney Complex, McCune-Albright syndrome, MEN-1)
• Patients diagnosed with glucocorticoid aldosteronism (GRA)
• Patients who are not biochemically euthyroid
• Patients who have undergone major surgery within the last month
• Patients with symptomatic cholelithiasis
• Diabetic patients with antidiabetic medications whose fasting blood glucose is poorly controlled, evidenced by HbA1C> 8%
• Patients with abnormal coagulation (TP or PTT raised 30% above normal limits)
• Patients receiving anticoagulants that affect the TP 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 occurred less than one year prior to study entry or clinically significant impairment of function cardiovascular
• Patients with liver disease such as cirrhosis, active chronic hepatitis, persistent chronic hepatitis or patients with ALT / AST greater than 2 X LSN, serum creatinine> 2.0 X LSN, serum bilirubin> 2.0 X LSN, serum albumin> 1, 5 X LSN
• Patients with RGB <3 X 10 ^ / 1; Hb <13 g / dl for men and <12 g / dl for women; PLT <100 X 10® / l
• Patients who have any current or previous illness that may interfere with the conduct of the study or the evaluation of their results in the opinion of the investigator or the medical monitor of the study
• Patients who are pregnant or breastfeeding, or who have reproductive potential and do not practice a medically acceptable method of birth control. Patients should use barrier contraceptive methods with condoms. If oral contraception is used, patients must have used this method for at least two months before enrollment and must agree to continue oral contraception throughout the course of the study and for one month after the last dose of study medication. Male patients who are sexually active should use condoms during the study and for 1 month after it
• History of immunocompromise, including a positive test result for HIV (Elisa and Western blot). An HIV test is not required, but prior medical history will be reviewed
• Patients who have a history of alcohol or drug abuse in the 6 months prior to receiving pasireotide
• Patients who have donated blood (400 mi or more) within 2 months prior to receiving pasireotide
• Patients who have participated in any clinical investigation with an experimental drug (other than pasireotide) within the month prior to administration
• Known hypersensitivity to somatostatin analogues
• Patients with active malignant disease within the previous five years (with the exception of basal cell carcinoma or carcinoma in situ of the neck)
• Patients with presence or suspicion of uncontrolled acute or chronic infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.<br><br>Measure:Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group<br>Timepoints:6 months<br>

Secondary Outcome Measures

Name	Time	Method

Related Trials