Treatment of Unresecable and/or Metastatic Merkel Cell Carcinoma by Somatostatine Analogues

What Was Tested

In this phase 2 trial, researchers set out to test Lanreotide.

This one-arm study, for which the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in one step (A'Hern RP.

Sample size tables for exact single-stage phase II designs.

It had 1 arm (groups): Only one arm (experimental).

All patients receive Lanreotide.

The registry classes the interventions as drug.

More on the Plan

Primary criterion Positive response at 3 months will be defined according to the RECIST 1.1 criteria (clinical and TDM evaluation will be done at 3 months): complete response (CR) or partial response (PR) or stable disease (SD) at 3 months.

This one-arm study, for which the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in one step.

Who Took Part

35 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: First line of treatment or more. Measurable disease: at least 20 mm by conventional techniques or 10 mm by spiral CT scan. WHO performance status ECOG 0-3. No other prior malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma or in situ cancer of the cervix. No other concurrent chemotherapy, immunotherapy or hormone therapy.

The full record lists 10 inclusion and 4 exclusion criteria; among the exclusions: previous hypersensibility to lanreotide treatment; complicated and untreated cholelithiasis; pregnancy or breast-feeding.

How the Study Was Run

The set-up was single-group and open-label.

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 2015-04 with completion listed for 2017-05-15.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of patient with positive response according to the RECIST 1.1 criteria (time frame: at 3 months).

It also tracked 2 secondary outcomes, for example Percentage of patient with positive response according to the RECIST 1.1 criteria and Number of Participants with Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Lanreotide in 35 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.