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Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas
Plain-language guide to NCT02333565: phase 2 interventional trial of Octreotide, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02333565
- Phase
- phase 2
- Status
- completed
- Start
- 2015-01-22
- Completion (planned or actual)
- 2019-01-21
- Participants
- 20 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Recurrent Meningiomas; Resistant Meningiomas
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Octreotide.
To determine if combination of everolimus and octreotide exert an anti-tumoral activity in recurrent and/or aggressive meningiomas growth with limited adverse effects.
It had 1 arm (groups): Combinaison everolimus and octreotide (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 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: Male and Female patients ≥ 18 years old with no maximum limited of age. Histologically proven meningioma grade II and III; grade I meningioma may also be included, if progression is documented (see criteria 3), particularly in case of skull base location. Patients must have failed surgery, and not amenable to a new curative intended surgery. Patients must have failed radiotherapy and/or radiosurgery. Patients who have given their written consent.
The full record lists 11 inclusion and 12 exclusion criteria; among the exclusions: patients with symptomatic lithiasis; contra indication to octreotide and everolimus; patients receiving other investigational agents or who received an investigative drug or therapy within the last 30 days.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Octreotide 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 2015-01-22 with completion listed for 2019-01-21.
It ran at 1 site in France.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: The Progression Free Survival rate (time frame: 36 months).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Octreotide in 20 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.