Trial of pasireotideLAR and Topotecan in Relapsed or Refractory Small Cell Lung Cancer

What Was Tested

The trial (phase 2) is built around Pasireotide.

Stimulation of these SSTR's lead to inhibition of angiogenesis and cell growth.

SOM230 also lower levels of IGF which is known to contribute to SCLC proliferation.

The registry classes the interventions as drug.

More on the Plan

The primary objectives of this study is to assess the progression-free survival (PFS) with the combination of SOM230 and topotecan in patients with SCLC who relapsed or progressed after front-line chemotherapy with cisplatin and etoposide.

The primary end point is progression free survival.

The secondary objective is response rate duration of response , overall survival , safety and tolerability.

Who Took Part

Enrollment: 28 planned participants were the target.

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 documented SCLC failed one chemotherapy with documentation of relapse or progressive disease. Measurable or evaluable disease by CT scan. If evaluable disease or measurable disease has been previously treated, this must show signs of tumor progression by CT. Karnofsky performance status of 80, Age ≥ 18 years and life expectancy of ≥12 weeks. Minimum of four weeks since any major surgery, completion of radiation or chemotherapy. Women of childbearing potential must have a negative serum pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating.

The full record lists 9 inclusion and 20 exclusion criteria; among the exclusions: prior topotecan or prior octreotide therapy; 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

The set-up was non-randomized, single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-07 with completion listed for 2016-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): progression free survival (time frame: 5 years).

It also tracked 1 secondary outcome, for example response rate and overall survival.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Pasireotide in 28 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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