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Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
Plain-language guide to NCT01789281: phase 4 interventional trial of Octreotide, 34 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01789281
- Phase
- phase 4
- Status
- completed
- Start
- 2013-05-14
- Completion (planned or actual)
- 2020-08-28
- Participants
- 34 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Neoplasms
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Octreotide.
It had 1 arm (groups): Everolimus (experimental).
The registry classes the interventions as drug.
More on the Plan
The study was designed to provide continued treatment with everolimus monotherapy to the subjects.
Subjects were allowed to continue combination therapy with Sandostatin LAR® Depot if they were receiving this combination therapy on the parent protocol.
A subject was considered to have reached end of study when everolimus treatment was permanently discontinued.
As per the original protocol, it was designed to collect only serious adverse events (SAEs) and protocol defined adverse events of special interest (AESIs).
Who Took Part
34 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.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: subject was permanently discontinued from everolimus study treatment in the parent study; subject was receiving everolimus in combination with an unapproved or experimental treatment.
How the Study Was Run
It was run as a single-group and open-label study.
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 2013-05-14 with completion listed for 2020-08-28.
It ran at 24 sites in United States (13), Italy (3), South Korea (2), Czechia (1), Netherlands (1) and Russia (1).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Octreotide in 34 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 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.