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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-26

Study Completion Date

2017-09-12

Brief Summary

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

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Detailed Description

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Conditions

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Non-functioning Pituitary Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pasireotide LAR

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

Group Type EXPERIMENTAL

Pasireotide LAR

Intervention Type DRUG

20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection

Interventions

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Pasireotide LAR

20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No