891TiP - Phase II study of dovitinib in first line metastatic or (non resectable primary) adrenocortical carcinoma (ACC). SOGUG study 2011-03

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anticancer agents
Endocrine Tumours
Therapy
Biological Therapy
Presenter Susana Hernando
Authors S. Hernando1, J. Garcia-Donas2, M. Climent3
  • 1Medical Oncology, Hospital Universitario Fundación Alcorcón, 28922 - Alcorcón (Madrid)/ES
  • 2Madrid, Hospital Madrid Norte San Chinarro Centro Integral Oncologico Clara Campal, 28050 - Madrid/ES
  • 3Medical Oncology Department, Instituto Valenciano de Oncologia, 46009 - Valencia/ES

Abstract

Background

Dovitinib is a novel targeted therapy, that has proven to inhibit, among other tyrosin kinases, the fibroblast growth factor receptor (FGFR). Since this pathway has been proposed to play a major role in ACC, we aim to test the clinical efficacy of dovitinib in this tumor.

Methods

An open label phase II trial has been designed in patients with advanced non-resectable ACC. The objective will be to obtain at least a 15% response rate according to RECIST criteria. Taking as a basis the two-stage Gehan model, 15 patients would need to be included in the first stage to demonstrate a treatment efficacy of at least 15%. Sample size calculation was done based on the following parameters, probability of Type I error α = 0.05, power of the test (1 - �) = 0.8. Main inclusion criteria are advanced non-resectable disease and no prior therapy (other than mitotane). Since this is an extremely unfrequent disease 7 institutions, members of the SOGUG (Spanish Oncology Genitourinary Group), will participate. The active support of a big collaborative group will guarantee candidate patients to be refereed to such institutions. So far 6 patients have already been included. Starting January 26th 2012 recruitment is scheduled to last around 12 months. Updated data regarding population of study and toxicity will be presented at the ESMO meeting. A translational research, including whole exome analysis, will be performed in order to improve our scarce knowledge of ACC.

Disclosure

All authors have declared no conflicts of interest.