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Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation
Plain-language guide to NCT04140409: phase 4 interventional trial of Octreotide, 10 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04140409
- Phase
- phase 4
- Status
- terminated early
- Start
- 2016-02-02
- Completion (planned or actual)
- 2019-06-30
- Participants
- 10 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Neuroendocrine Tumors; Carcinoid Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Octreotide.
This is a multi-centric prospective interventional study in which patients with a symptomatic GEP-NET will receive octreotide LAR every 2, 3 or 4 weeks.
It had 1 arm (groups): Treatment (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 10 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: Histologically or cytologically confirmed GEP NET. Appearance of carcinoid syndrome maximum 6 months before the inclusion. Evaluable or measurable disease (RECIST 1.1) WHO ECOG performance status 0-2. Positive somatostatin receptor scintigraphy. Life expectancy of at least 12 weeks.
The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: current pregnancy or breast feeding; concomitant anti-tumoral treatment, except external beam radiotherapy.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Octreotide 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 2016-02-02 with completion listed for 2019-06-30.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Treatment succes vs treatment failure (time frame: 2 years).
It also tracked 7 secondary outcomes, for example Symptoms, Rate of diarrhea and flushes, Changes in Quality of life, Effect on tumor control and Toxicities.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Octreotide in 10 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Octreotide compound page, all human trials.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
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.