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

• Status: Completed
• Trial end date: 2017-09-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Pasireotide

Criteria

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