Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors

What Was Tested

This registered phase 1, phase 2 trial tested Lanreotide.

This is an Open-Label Phase I/II Study of daily cabozantinib plus lanreotide every 4 w eeks to treat advanced G1-2 gastroentero-pancreatic neuroendocrine tumor (GEP-NET) patients who failed to one line or more than one line of small molecule kinase inhibitor or well-differentiated (W-D) G3 GEP-NET who failed to one line of small molecule kinase inhibitor or chemotherapy.

It had 1 arm (groups): Cabozantinib and Lanreotide (experimental).

The registry classes the interventions as drug.

More on the Plan

The secondary objectives are the objective response rate, overall survival, toxicities and biomarker analysis of this regimen.

Four weeks is a cycle.

Who Took Part

49 planned participants were the target.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Radiologic progression within 12 months of entry. Age≥ 20 years old and ECOG Performance Status ≤ 1. Absolute neutrophil count (ANC) ≥ 1500/µL without granulocyte colony- stimulating factor support. White blood cell count ≥ 2500/µL. Platelets ≥ 100,000/µL without transfusion.

The full record lists 24 inclusion and 29 exclusion criteria; among the exclusions: prior use of cabozantinib. (prior use of lanreotide is acceptable); congestive heart failure new york heart association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias; uncontrolled hypertension defined as sustained blood pressure (bp) \> 140 mm hg systolic or \> 90 mm hg diastolic despite optimal antihypertensive treatment.

How the Study Was Run

It was run as a single-group and open-label study.

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 2021-09-17 with completion listed for 2027-08-31.

It ran at 11 sites in Taiwan (11).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression free survival.

It also tracked 6 secondary outcomes, for example Response rate, Overall survival, Toxicities, Genetic study, Somatic mutation and circulating tumor cells.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Lanreotide in 49 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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