Study of efficacy and safety of pasireotide LAR in patients with inadequately controlled acromegaly.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 123

Inclusion Criteria

1.Written informed consent must be obtained prior to any screening procedures
2.Male and female patients = 18 years of age
3.Patients with confirmed diagnosis of inadequately controlled acromegaly as evidenced by the following:
•A mean GH concentration of a 5-point profile over a 2-hour period = 1 µg/L and sex- and age-adjusted IGF-1 >1.3 x ULN
4.Patients treated with high dose of octreotide LAR (30 mg or 40 mg) or lanreotide ATG (120 mg) given as monotherapy for at least 3 months prior to screening (Visit 1)
•Note: Patients currently being treated with octreotide LAR 30 mg from countries where the octreotide LAR 40 mg dose is approved at the time of screening will start a run- in phase in which they will receive the 3 injections of octreotide LAR 40 mg before being evaluated for eligibility for the core phase of the study

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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1.Concomitant treatment with other medications known to reduce GH and or IGF-1, other than octreotide LAR or lanreotide ATG, unless discontinued 3 months prior to visit 1 (screening)
2.Patients with compression of the optic chiasm causing any visual field defect that requires surgical intervention
3.Diabetic patients with poor glycaemic control as evidenced by HbA1c >8% at Visit 1 for Group 2 and at both Visit 1 and Visit 5 for Group 1
4.Patients who are hypothyroid and not on adequate replacement therapy
5.Patients with symptomatic cholelithiasis and acute or chronic pancreatitis
6.Patients with clinically significant valvular disease
7.Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF >450 ms in males, and >460 ms in females
8.Hypokalaemia, hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome or concomitant medications with known risk of Torsades de pointes (TdP). Drugs with posible risk of TdP should be avoided whenever feasible.
9.Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function
10.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
11.Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST > 2.0 X ULN, serum bilirubin >2.0 X ULN
12.Presence of Hepatitis B surface antigen (HbsAg) or Hepatitis C antibody test (anti-HCV)
13.Patients with serum creatinine >2.0 X ULN
14.Patients with WBC <3 X 109/L; Hb 90% < LLN; PLT <100 X 109/L
15.Patients with the presence of active or suspected acute or chronic uncontrolled infection
16.Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening)
17.Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
18.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)
19.History of syncope or family history of idiopathic sudden death
20.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
21.Known hypersensitivity to somatostatin analogues or any other component of the pasireotide LAR
22.Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving pasireotide
23.Patients who have given a blood donation (of 400 ml or more) within 2 months before receiving pasireotide
24.Patients who have participated in any clinic

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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