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Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
Plain-language guide to NCT01283542: phase 2 interventional trial of Pasireotide, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01283542
- Phase
- phase 2
- Status
- completed
- Start
- 2012-11-26
- Completion (planned or actual)
- 2017-09-12
- Participants
- 20 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Non-functioning Pituitary Adenoma
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Pasireotide.
It had 1 arm (groups): Pasireotide LAR (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 20 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: Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: previous pituitary surgery; previous medical treatment for pituitary tumor; patients who had received pituitary irradiation within 10 years prior to randomization.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Pasireotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-11-26 with completion listed for 2017-09-12.
It ran at 7 sites in Brazil (7).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 19 secondary outcomes, for example Tumor Volume Main Phase (FAS), Tumor Volume in Extension Phase (FAS), Tumor Volume Change From Baseline in Main Phase (FAS), Tumor Volume Change From Baseline in Extension Phase (FAS), Tumor Volume Percent Change From Baseline in Main Phase (FAS) and Tumor Volume Percent Change From Baseline in Extension Phase (FAS).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Pasireotide in 20 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.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.