A phase III, multicenter, randomized, parallel-group study to assess the efficacy and safety of double-blind pasireotide LAR 40 mg and pasireotide LAR 60 mg versus open-label octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 219

Inclusion Criteria

•Male and female patients = 18 years of age
•Patients with written informed consent prior to any study related activity
•Patients with inadequately controlled acromegaly as defined by
•a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L
and
•sex- and age adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
•Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to randomization. The maximum indicated dose for octreotide LAR is 30 mg and for lanreotide ATG is 120 mg
•Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery

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

•Patients who have received pasireotide (SOM 230) prior to enrolment
•Concomitant treatment with GHR-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to randomization (8-week wash-out period)
•Patients with compression of the optic chiasm causing acute clinically significant visual field defects
•Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
•Patients who have received pituitary irradiation within 10 years prior to randomization
•Patients who have undergone major surgery/surgical therapy for
any cause within 4 weeks prior to randomization
•Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
•Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8% at screening. Patients with a known history of impaired fasting glucose or diabetes mellitus with HbA1c<8% may be included; however, blood glucose and anti diabetic treatment must be monitored closely throughout the trial and adjusted as necessary
•Patients with symptomatic cholelithiasis
•Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated partial thromboplastin time)
•Patients who have congestive heart failure (NYHA Class III or
IV), unstable angina, sustained ventricular tachycardia,
ventricular fibrillation, advanced heart block or a history of acute myocardial infarction within the 6 months preceding randomization
•Screening or baseline (predose) QTcF > 450 msec
•History of syncope or family history of idiopathic sudden death
•Sustained or clinically significant cardiac arrhythmias
•Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia or high-grade AV block.
•Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson’s disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
•Concomitant medication(s) known to increase the QT interval
•Patients with liver disease such as cirrhosis, chronic active
hepatitis or chronic persistent hepatitis, or patients with ALT
and/or AST more than 2 x ULN, serum bilirubin > 2 x ULN, serum albumin < 0.67 x LLN
•Patients with serum creatinine > 2.0 x ULN
•Patients with WBC <3 x 109/L; Hgb < 90% LLN; PLT <100 x 109/L
•Patients with any current or prior medical condition that, in the judgment of the investigator may interfere with the conduct of the study or the evaluation of the study results
•History of immunocompromise, including a positive HIV test
result (ELISA and Western blot). A HIV test will not be required;
however, previous medical history will be reviewed
•Known hypersensitivity to somatostatin analogues or any other
component of pasireotide LAR
•Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ
of the cervix)
•Patients with the presence of active or suspected acute or
chronic uncontrolled infection
•Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception is sufficient (pill or diaphragm) and the p

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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