Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors

What Was Tested

This registered phase 2 trial tested Pasireotide.

Baseline and monthly visits on therapy will monitor plasma levels of POMC, other pituitary function, safety labs, glucose tolerance, physical examination, and visual fields.

It had 1 arm (groups): Pasireotide LAR Therapy (experimental).

Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed.

The registry classes the interventions as drug.

More on the Plan

Clinically non-functioning pituitary adenomas (CNFAs), the subtype of pituitary adenomas that does not appear to secrete biologically active hormone nor to have a characteristic clinical phenotype, are the most common type of pituitary macroadenoma at diagnosis.

There is currently no option for medical therapy of CNFA, in general, or specifically of silent corticotroph tumors.

Current therapy consists primarily of surgical removal of the tumor and for recurrent or residual tumors, repeated surgery and/or radiotherapy.

In very aggressive tumors, chemotherapy has been tried with some success.

Who Took Part

The registry lists 4 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Plasma POMC level \> upper limit of normal. Prior pituitary tumor surgery with residual or recurrent pituitary tumor visible on MRI scan that is ≥ 5 mm from the optic chiasm. Surgical resection of the pituitary adenoma must have occurred two or more months prior to enrollment. If patients have undergone pituitary radiotherapy they must have completed their course of radiotherapy at least 2 months prior to study screening. No prior somatostatin analog therapy.

The full record lists 10 inclusion and 30 exclusion criteria; among the exclusions: patients with cushing's disease (biochemical evidence of hypercortisolism); patients with compression of the optic chiasm causing any visual field defect that requires surgical intervention; patients who are hypothyroid or adrenally insufficient and not on adequate replacement therapy.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Pasireotide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-07-10 with completion listed for 2020-03-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Plasma Proopiomelanocortin (POMC) Levels (time frame: Baseline, 12 months).

It also tracked 1 secondary outcome, for example Change in Pituitary Tumor Volume.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Pasireotide in 4 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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