LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)

What Was Tested

The trial (phase 2) is built around Lanreotide.

It had 1 arm (groups): lanreotide arm (experimental).

Patients with a histopathologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability who meet the inclusion/exclusion criteria. Approximately 40 patients will be enrolled.

The registry classes the interventions as drug.

More on the Plan

Lanreotide is FDA approved for certain kinds of neuroendocrine tumors.

The method of analysis that will be used has been previously described.

For this assessment a minimum of three tumor measurements will be required.

Who Took Part

10 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 must give signed informed consent before any study-related activities are conducted. Histologically or cytologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability. Patients may not have had prior octreotide, long acting release (LAR)-octreotide, lanreotide or a therapeutic radiolabeled somatostatin analog (PRRT). Eastern Cooperative Oncology Group (ECOG) 0-2. Life expectancy of greater than 12 weeks.

The full record lists 20 inclusion and 15 exclusion criteria; among the exclusions: patient has a history of known allergy or hypersensitivity to:; investigational drug or any components of its formulation; lanreotide, octreotide or any other somatostatin analog.

How the Study Was Run

Design: 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 2019-06-17 with completion listed for 2027-03.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Rate of tumor growth (time frame: minimum of 32 weeks, up to 48 weeks).

It also tracked 4 secondary outcomes, for example Overall survival (OS), Overall Response Rate (ORR), Progression-free survival and Magnitude of change in analyte levels.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Lanreotide in 10 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lanreotide compound page, all human trials.