AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors

What Was Tested

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

RATIONALE: AMG 706 and octreotide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well AMG 706 and octreotide work in treating patients with low-grade neuroendocrine tumors.

It had 1 arm (groups): AMG 706+Octreotide (experimental).

The registry classes the interventions as drug.

More on the Plan

OBJECTIVES: Primary * Determine the 4-month progression-free survival (PFS) of patients with low-grade neuroendocrine tumors treated with AMG 706 and octreotide acetate.

OUTLINE: This is a multicenter study.

Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28.

Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Who Took Part

The registry lists 46 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: Histologically confirmed low-grade neuroendocrine neoplasm. Radiographic evidence of disease progression after any prior systemic therapy, chemoembolization, bland embolization, or observation, defined by either of the following:. Appearance of a new lesion. Tissue block from original diagnostic or surgical specimen required. Negative pregnancy test.

The full record lists 22 inclusion and 15 exclusion criteria; among the exclusions: prior procedures that would adversely affect intestinal absorption; prior anti-vascular endothelial growth factors; concurrent chemotherapy or radiation therapy.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Octreotide 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 2008-11-07 with completion listed for 2014-10.

It ran at 112 sites in United States (112).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Four-month Progression-free Survival Rate.

It also tracked 2 secondary outcomes, for example Overall Survival and Objective Response Rate.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 46 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.