A Phase I, Exploratory, Intra-patient Dose Escalation Study to Investigate the Preliminary Safety, Pharmacokinetics, and Anti-tumor Activity of Pasireotide (SOM230) s.c.Followed by Pasireotide LAR in Patients With Metastaticmelanoma or Metastatic Merkel Cell Carcinoma

What Was Tested

This registered phase 1 trial tested Pasireotide.

In the screening phase patient will be informed of all aspects of the study and sign informed consent forms and then be screened for study eligibility.

It had two arms (groups): Pasireotide sub-cutaneous formulation (experimental) and Pasireotide long acting release (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 10 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: Patients must have histologically or cytologically confirmed unresectable (stage III) and/or metastatic (stage IV) melanoma or unresectable and/or metastatic Merkel cell carcinoma. Melanoma patients should have no mutation in BRAF and NRAS genes. Patients should have lesions that can be biopsied, in addition measurable and non-measurable metastatic lesions and at 1 lesion suitable for 18FDG-PET scan or CT/MRI. ECOG Performance Status of 0 or 1. Presence of measurable or non-measurable disease according to RECIST 1.0.

The full record lists 6 inclusion and 35 exclusion criteria; among the exclusions: patient with primary uveal melanoma; patients for whom standard treatment is available and indicated due to rapidly progressive or aggressive disease; patients who received more than 3 prior lines of systemic therapy for the treatment of the disease.

How the Study Was Run

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

The participants were allocated by chance, so the Pasireotide group and the comparison group should start out alike.

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 2012-11 with completion listed for 2015-04.

It ran at 3 sites in Switzerland (2) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of patients with AEs, SAEs (time frame: Week 8). Number of patients with laboratory abnormalities and changes in laboratory values (time frame: Week 8). Number of patients with electrocardiographic abnormalities and changes in electrocardiograms readings (time frame: Week 8).

It also tracked 9 secondary outcomes, for example Changes in laboratory values, electrocardiograms readings, and vital signs values at study completion, Number of patients with AEs, SAEs at study completion, Number of patients with electrocardiographic abnormalities and changes in electrocardiograms readings at study completion, Number of patients with laboratory abnormalities and changes in laboratory values at study completion and Number of patients with vital sign abnormalities and changes in vital signs at study completion.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Pasireotide in 10 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.