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Combination of Lanreotide Autogel [amount hidden] and Temozolomide in Progressive GEP-NET
Plain-language guide to NCT02231762: phase 2 interventional trial of Lanreotide, 57 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02231762
- Phase
- phase 2
- Status
- completed
- Start
- 2014-10
- Completion (planned or actual)
- 2016-12
- Participants
- 57 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Gastroenteropancreatic Neuroendocrine Tumors
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Lanreotide.
All progressive tumours classified according to Response Evaluation Criteria In Solid Tumours (RECIST, 1.1).
It had 1 arm (groups): one (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 57 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: Provision of written informed consent prior to any study related procedures. Measurable disease according to RECIST 1.1. Metastatic disease confirmed by CT/MRI. Functioning or non-functioning NET (G1, G2). Positive Octreo-Scan (≥ Grade 2 Krenning scale) or positive DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid)-TATE (Tyr3-Thre8-Octreotide or DOTA-Tyr3-octreotate)/TOC (Tyr3-octreotide) -PET (Positron-Emission-Tomography) -CT within 12 months prior to screening.
The full record lists 7 inclusion and 2 exclusion criteria; among the exclusions: has the diagnosis of insulinoma; has a diagnosis of a multiple endocrine neoplasia (men).
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Lanreotide 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 2014-10 with completion listed for 2016-12.
It ran at 10 sites in Germany (9) and Austria (1).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Disease Control Rate (DCR) After 6 Months (time frame: 6 months).
It also tracked 16 secondary outcomes, for example DCR After 12 Months, Progression-Free Survival (PFS) Within 12 Months, Time To Response (TtR) Within 12 Months, Duration of Response (DoR) Within 12 Months, The Number of Subjects With a Biochemical Response Using Chromogranin-A (CgA) Levels After 6 Months and The Number of Subjects With a Biochemical Response Using CgA Levels After 12 Months.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Lanreotide in 57 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.