Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas

What Was Tested

This registered phase 2, phase 3 trial tested Octreotide.

It had two arms (groups): Axitinib + Sandostatin LAR (experimental) and Placebo + Sandostatin LAR (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

In the first part of the study (Phase II), 105 patients were enrolled.

The second part of the study is the expansion to Phase III, which is expected to include 148 additional patients.

Patients will be randomized to receive Sandostatin LAR with axitinib or Sandostatin LAR with placebo until disease progression or unacceptable toxicity occurs.

Who Took Part

256 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: G1-G2 neuroendocrine tumor (WHO 2010) of histologically confirmed non-pancreatic origin, functioning and nonfunctioning. Metastatic or locally advanced disease not amenable to treatment with curative intent. Clinical and/or radiological disease progression documented in the 12 months prior to study entry. Prior treatment with somatostatin analogues is allowed. Prior treatment with interferon is allowed.

The full record lists 25 inclusion and 23 exclusion criteria; among the exclusions: the following types of endocrine tumors will not be included: paraganglioma, adrenal endocrine tumor, thyroid, parathyroid, or pituitary; gastrointestinal abnormalities, including:; inability to swallow oral medication;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

The Octreotide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-11 with completion listed for 2023-12-31.

It ran at 26 sites in Spain (22), Italy (2), Germany (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Objective Response Rate (ORR) (Investigator Assessment), Biochemical Response (5-OH-indoleacetic Acid and Chromogranin A), Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0) and Objective Response Rate (ORR) (Central Blinded Assessment).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Octreotide in 256 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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