A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer

What Was Tested

This registered phase 2 trial tested Octreotide.

It had two arms (groups): Carcinoid tumor (experimental) and Islet cell carcinoma (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

43 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: The participant has well-differentiated or moderately-differentiated, histologically confirmed neuroendocrine carcinoma, including carcinoid of any location and islet cell tumors. The participant has metastatic disease at the time of study entry. The participant is age ≥ 18 years. The participant is receiving depot octreotide therapy at the time of enrolling into the study. The participant is no longer a candidate for surgery, embolization, or radiofrequency ablation therapy.

The full record lists 19 inclusion and 12 exclusion criteria; among the exclusions: the participant has uncontrolled brain or leptomeningeal metastases; the participant is receiving any other investigational agent(s); the participant has received therapeutic radiolabeled somatostatin analogues.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2009-02 with completion listed for 2011-07.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months.

It also tracked 10 secondary outcomes, for example Percentage of Participants With a Biochemical Response Rate, Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs), PK: Half-life (t 1/2) Cycle 1, PK: Area Under Concentration (AUCinf) Cycle 1, PK: Clearance (CL) Cycle 1 and PK: Volume at Steady State (Vss) Cycle 1.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Octreotide in 43 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.