Pasireotide in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors

What Was Tested

In this phase 1 trial, researchers set out to test Pasireotide.

SOM230 is an investigational drug that is similar to Sandostatin LAR.

Sandostatin is an approved drug for the use of treating symptoms of neuroendocrine tumors.

It had 1 arm (groups): Pasireotide and RAD001 (experimental).

The registry classes the interventions as drug.

More on the Plan

* Participants will be receiving two study medications, SOM230 and RAD001, during each treatment cycle.

Each treatment cycle lasts 4 weeks. * For the first four weeks of treatment, the participant will self-administer the SOM230 twice a day by subcutaneous injection.

If they tolerate the SOM230 after 4 weeks, they will switched to the long-acting SOM230 which will be administered during scheduled treatment visits once every 4 weeks.

The pK samples will be taken right before the study drug is administered and then 1, 2, 3, and 5 hours later.

Who Took Part

Enrollment: 22 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: 18 years of age or older. ECOG Performance Status 0,1, or 2. Life expectancy 12 weeks or more. Adequate bone marrow, liver and renal function as outlined in the protocol.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: chronic treatment with systemic steroids or another immunosuppressive agent; immunization with attenuated live vaccines during study or within 1 week of study entry; uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Pasireotide 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 2008-10 with completion listed for 2014-09.

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

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example To make a preliminary assessment of the anti-tumor activity of the combination in this patient population, To determine the objective response rate, To determine the duration of response and To determine the progression free survival and overall survival of patients receiving this combination.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Pasireotide in 22 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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