Acromegaly
Conditions
Interventions
Sponsors
Faculdade de Medicina - Universidade Federal do Rio de Janeiro (UFRJ)
Faculdade de Medicina - Universidade Federal do Rio de Janeiro (UFRJ)
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 80 years; clinical indication of surgery as part of the treatment; laboratory and clinical confirmation of acromegaly; Signature of written informed consent.
Exclusion criteria
Exclusion criteria: Contraindications to surgery due to high surgical risk; Previous radiotherapy for pituitary adenoma treatment; Presence of AIP mutation; Medical treatment with somatostatin analogues, dopamine agonists or GH antagonist before surgery; Patients with compression of the optic chiasm causing any visual field defect that requires surgical intervention; Diabetic patients with poor glycaemic control as evidenced by HbA1c >8%; Patients with symptomatic cholelithiasis and acute or chronic pancreatitis; Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF >450 ms in males, and >460 ms in females; Hypokalaemia, hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome or concomitant medications with known risk of Torsades de pointes (TdP); 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 myocardial infarct less than one year prior to study entry or clinically significant impairment in cardiovascular function; 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; 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; Presence of Hepatitis B surface antigen (HbsAg) or Hepatitis C antibody test (anti-HCV); Patients with serum creatinine >2.0 X ULN; Patients with white blood cells <3 X 109/L; Hb 90% < LLN; Platelets <100 X 109/L; Patients with active malignant disease in the last five years (with the exception of basocelular carcinoma or in situ cervix carcinoma); Patients with the presence of active or suspected acute or chronic uncontrolled infection; Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior screening; 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); History of syncope or family history of idiopathic sudden death; History of immunocompromise, including a positive HIV test result (ELISA and Western blot); known hypersensibility to somatostatin analogs or any other component of pasireotide; Sexually active males unless they use a condom during intercourse while taking drug and for 3 months following last dose of pasireotide and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid; Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test; Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and 3 months following last dose of pasireotide. Highly effective contraception methods include: abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; Female sterilizati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the percentage of patients with low AIP expression and with high AIP expression that achieve normalization of GH (basal GH <1.0 mcg/L) and IGF-I (normal age-adjusted IGF-I) or biochemical response (at least 50% decrease in GH and/or IGF-I levels) after six months of treatment with pasireotide LAR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of miR-34a levels between patients that achieve normalization of GH (basal GH <1.0 mcg/L) and IGF-I (normal age-adjusted IGF-I) after six months of treatment with pasireotide LAR and those that did not achieve; Positive correlation between the AIP score at immunohistochemistry and the reduction of GH and IGF-I levels after six months pasireotide LAR treatment; Elevation of AIP expression (measured by Western-blot) in cell lines treated with pasireotide in comparison with those not treated; Toxicity will be assessed using the National Cancer Institute-Common Toxicology Criteria Adverse Events version 4 (NCI-CTCAE v.4.03) | — |
Countries
Brazil
Contacts
Public ContactLeandro Kasuki;Nelma Verônica de Pinho;Dória da Silva
Hospital Universitário Clementino Fraga Filho - UFRJ;Hospital Universitário Clementino Fraga Filho - UFRJ
Outcome results
None listed