Clinical Trial: Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors
Brief Summary: This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).
Detailed Summary:
Sponsor: Onxeo
Current Primary Outcome:
- to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU [ Time Frame: throughout the study ]
- to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors [ Time Frame: throughout the study ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Onxeo
Dates:
Date Received: December 18, 2006
Date Started: September 2005
Date Completion:
Last Updated: July 7, 2015
Last Verified: July 2015
