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Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours
Plain-language guide to NCT00326469: phase 2 interventional trial of Lanreotide, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00326469
- Phase
- phase 2
- Status
- completed
- Start
- 2006-05
- Completion (planned or actual)
- 2009-11
- Participants
- 30 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Neuroendocrine Tumours
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Lanreotide.
It had 1 arm (groups): 1 (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 30 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: Patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification. Patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours) present measurable disease. Patients with progressive disease in the previous 6 months before their inclusion in the study. Patients with positive IN111 octreotide scintigraphy.
The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: patients with surgically removable localised disease; patients with progressive disease in the first six months of being diagnosed; patients with intestinal obstruction due to a carcinoid tumour.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Lanreotide 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 2006-05 with completion listed for 2009-11.
It ran at 27 sites in Spain (27).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 3 secondary outcomes, for example Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel and Tolerance.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Lanreotide in 30 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 Lanreotide compound page, all human trials.
Our Notes on the Compound
Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.
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.