Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.

An Open-Label, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of Pasireotide LAR on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma

This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.

Inclusion Criteria:

• Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

• Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
• Previous pituitary surgery
• Previous medical treatment for pituitary tumor
• Patients who had received pituitary irradiation within 10 years prior to randomization
• Prolactin (PRL) levels > 100 ng/mL. PRL evaluation should have been performed with diluted samples to ensure "hook effect." was avoided
• Patients who presented prolactinomas, acromegaly or Cushing's disease
• Patients with compression of the optic chiasm causing acute clinically significant visual field defects