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

Novartis

Status and phase: Completed; Phase 2

Conditions: Non-functioning Pituitary Adenoma

Treatments: Drug: Pasireotide LAR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01283542

CSOM230D2401

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Pasireotide LAR

Experimental group

Description:

All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks

Treatment:

Drug: Pasireotide LAR