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A Study of Pasireotide in People With Prolactinoma
Plain-language guide to NCT06295952: phase 2 interventional trial of Pasireotide, 10 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06295952
- Phase
- phase 2
- Status
- recruiting participants
- Start
- 2024-02-27
- Completion (planned or actual)
- 2027-02
- Participants
- 10 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Prolactin-Producing Pituitary Tumor
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Pasireotide.
It had 1 arm (groups): Pasireotide (experimental).
The registry classes the interventions as drug and other.
Who Took Part
Enrollment: 10 planned participants were the target.
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: Age 18 or older. Male and female patients with prolactinomas with at least one of the following criteria:. Contraindication to DA treatment (e.g., patients requiring dopamine antagonist therapy or other therapy that is contraindicated). Patients are not considered candidates for surgery (e.g., poor surgical candidates, inoperable tumors, patients who refuse surgical treatment, or for whom surgery is deemed not appropriate treatment). For patients with a history of pituitary radiation, the following criteria must be present:.
The full record lists 29 inclusion and 11 exclusion criteria; among the exclusions: additional pituitary tumor directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy; any pituitary surgery within 14 days of enrollment; patients who are not euthyroid as judged by the investigator.
How the Study Was Run
The set-up was single-group and open-label.
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.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2024-02-27 with completion listed for 2027-02.
It ran at 7 sites in United States (7).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: biochemical response rate (time frame: within 24 weeks of treatment).
It also tracked 1 secondary outcome, for example radiographic response.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Pasireotide in 10 people.
Its size is small, so on its own it can only give an early look.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
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.