A phase II evaluation of nintedanib (BIBF-1120) in the treatment of recurrent or persistent endometrial cancer: an NRG Oncology/Gynecologic Oncology Group Study.

ABSTRACT:

Introduction

Patients presenting with advanced, recurrent, or metastatic endometrial cancer have limited treatment options. On behalf of the Gynecologic Oncology Group, we conducted this phase II trial of nintedanib (BIBF 1120), a potent small molecule triple receptor tyrosine kinase inhibitor of PDGFR α and β, FGFR 1/3, and VEGFR 1-3, in this population.

Objectives

The primary objectives were to estimate event-free survival (EFS) at 6 months and the proportion of patients who have an objective tumor response. In addition, we sought to determine the nature and degree of toxicity. Secondary objectives were to estimate progression-free and overall survival.

Methods

This was a two-stage, single-arm phase II study. Eligible patients were treated with single-agent nintedan

SUBMITTER: Dizon DS 

PROVIDER: S-EPMC4373614 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature