Phase I, open-label study of pasireotide in patients with BRAF-wild type and NRAS-wild type, unresectable and/or metastatic melanoma.

ABSTRACT:

Introduction

Somatostatin analogues exert antitumour activity via direct and indirect mechanisms. The present study was designed to assess the safety and efficacy of pasireotide in patients with BRAF-wild type (WT) and NRAS-WT metastatic melanoma.

Patients and methods

Patients with unresectable and/or metastatic melanoma or Merkel cell carcinoma were eligible. Pasireotide was administered at different doses for ≤8 weeks in dose-escalation phase, followed by long-acting pasireotide 80 mg or lower dose in case of toxicity in follow-up phase up to six additional months. Primary endpoint was safety in the first 8 weeks of dose-escalation phase.

Results

The study was terminated early due to slow recruitment. Of the 10 patients with metastatic melanoma enrolle

SUBMITTER: Dummer R 

PROVIDER: S-EPMC6069912 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature