Pasireotide & Everolimus in Adult Patients With Radioiodine-Refractory Differentiated & Medullary Thyroid Cancer

What Was Tested

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

The investigators also want to establish the best manner of taking the two medications when used together to treat thyroid cancer.

In particular, the investigators want to know if it is better to give both at the same time or add a second medication after the first one has stopped working.

It had three arms (groups): Arm A (Everolimus alone) (experimental), Arm B (Pasireotide alone) (experimental) and Arm C (Everolimus + Pasireotide) (experimental).

CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression.

CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression.

CURRENTLY CLOSED TO ACCRUAL.

The registry classes the interventions as drug.

Who Took Part

The registry lists 42 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: Histologic or cytologic confirmation of thyroid cancer (papillary, follicular, medullary); histologic variants such as Hurthle and tall cell variants are allowed. Biochemical or radiologic documentation of disease progression within the last 12 months prior to enrollment. Presence of at least one site of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1. Patient must have radioiodine refractory disease as defined by one or more of the following conditions:. All cases of medullary thyroid carcinoma.

The full record lists 19 inclusion and 36 exclusion criteria; among the exclusions: prior treatment with not more than 1 systemic agent; chronic treatment with systemic steroids or another immunosuppressive agent; patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.

How the Study Was Run

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

Because people in this Pasireotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2010-11 with completion listed for 2019-02.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Response Per Responsive Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) (time frame: Through study completion, an average of 1 year).

It also tracked 1 secondary outcome, for example Number of Participants With Progression-free Survival.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 42 people.

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

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