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SOM230 Ectopic ACTH-producing Tumors
Plain-language guide to NCT02780882: phase 2 interventional trial of Pasireotide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02780882
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2015-12
- Completion (planned or actual)
- 2018-12
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Ectopic ACTH Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Pasireotide.
It had 1 arm (groups): Pasireotide (experimental).
The registry classes the interventions as drug.
Who 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: Written informed consent obtained prior to any screening procedures. Male or female patients aged 18 years or greater. Confirmed non-pituitary ectopic-ACTH secreting tumor. Well differentiated, and low or intermediate grade (WHO classification G1-2) neuroendocrine tumor. Mean 24-hour urinary free cortisol level of at least 1.5 x the upper limit of the normal range, and a morning plasma ACTH level of \> 5 ng/L.
The full record lists 6 inclusion and 30 exclusion criteria; among the exclusions: patients with highly malignant acth-secreting tumors, i.e. small-cell lung carcinomas, medullary thyroid carcinomas, and pheochromocytomas; patients with poorly differentiated neuroendocrine tumors (who classification g3); patients with cushing's syndrome due to pituitary acth secretion.
How the Study Was Run
It was run as a single-group and open-label study.
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 2015-12 with completion listed for 2018-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 14 secondary outcomes, for example Number of participants with abnormal laboratory values for urine free cortisol, Number of participants with abnormal laboratory values for serum cortisol levels, Number of participants with abnormal laboratory values for salivary cortisol levels, Number of participants with abnormal laboratory values for Hemoglobin A1C (HbA1C), Number of participants with abnormal laboratory values for fasting blood glucose and Number of participants with abnormal laboratory values for blood electrolytes.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Pasireotide in people.
It was withdrawn before enrolling anyone; 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.