Overview

HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST criteria. This study was originally intended to be a phase 1/phase 2. The protocol was amended to make this study a phase 1 only.
Phase:
Phase 1
Details
Lead Sponsor:
Yale University
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Capecitabine
Histone Deacetylase Inhibitors
Vorinostat