Clinical Trial Details
Braintumor Website

[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01620138 : Expression Profile of Somatostatin Receptors and Dopamine Receptor 2 in Non-functioning Pituitary Adenomas and Resistant Prolactinomas: Correlation With in Vivo Response to Pasireotide and Cabergoline
PhasePhase 2/Phase 3
AgesMin: 18 Years Max: N/A
Inclusion Criteria (for patients with NFPA):

- Male or female patients aged 18 years or greater;

- Patients with confirmed diagnosis of NFPA evidenced by:

- MRI confirmation of pituitary adenoma.

- No pituitary tumoral hormone hypersecretion.

- Patients with no previous medical treatment;

- Patients who had been submitted to surgery but not cured. Lack of cure is defined as
presence of remnant tumor on MRI at least three months after surgery (without any
possible misinterpretation of postsurgical changes); and

- Patients who signed the informed consent;

Inclusion Criteria (for patients with resistant prolactinomas):

- Male or female patients aged 18 years or greater;

- Patients with confirmed diagnosis of resistant prolactinoma by lack of prolactin
normalization with a tolerated cabergoline dosage during 12 weeks;

- Patients who had been submitted to surgery due to resistance to cabergoline and not
cured. Lack of cure is defined as lack of serum prolactin normalization or complete
removal of tumor load; and

- Patients who signed the informed consent.

Exclusion Criteria (for both):

- Previous pituitary radiotherapy;

- High risk for transsphenoidal surgery;

- 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, 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;

- Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTc
> 480 ms, hypokalemia, family history of long QT syndrome, and concomitant
medications known to prolong QT interval;

- 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 < 0.67 X LLN;

- Patients with WBC < 3 X 109/L; Hgb < LLN; PLT < 100 X 109/L;

- Patients who have any current or prior medical condition that can interfere with the
conduct of the study or the evaluation of its results in the opinion of the

- Female patients who are pregnant or lactating, or are of childbearing potential and
not practicing a medically acceptable method for birth control. Female patients must
use barrier contraception with condoms. If oral contraception is used, the patient
must have been practicing this method for at least two months prior to enrollment and
must agree to continue the oral contraceptive throughout the course of the study and
for one month after the last dose of study drug. Male patients who are sexually
active are required to use condoms during the study and for 1 month afterwards; and

- Patients who have a history of alcohol or drug abuse in the 6 month period prior to
receiving pasireotide.
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