Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas

What Was Tested

This registered phase 2, phase 3 trial tested Pasireotide.

The study of the receptors by quantitative messenger ribonucleic acid (mRNA) expression levels and immunohistochemistry analysis might end with a better understanding of these tumors.

Besides that, it will be assessed the in vitro and in vivo responses to pasireotide (for NFPA and prolactinomas) and cabergoline (for NFPA).

It had two arms (groups): Pasireotide (active comparator) and cabergoline (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 21 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female patients aged 18 years or greater. Patients with confirmed diagnosis of NFPA evidenced by: magnetic resonance imaging (MRI) confirmation of pituitary adenoma and No pituitary tumoral hormone hypersecretion. Patients with no previous medical treatment. Patients who signed the informed consent.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: previous pituitary radiotherapy; high risk for transsphenoidal surgery; patients with symptomatic cholelithiasis.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Pasireotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Pasireotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-03 with completion listed for 2012-06.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Tumor Volume Changes for NFPA and Prolactin Level Changes for Prolactinoma (time frame: Baseline to six months).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Pasireotide in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Pasireotide compound page, all human trials.