NCT00413322

Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tumor

Interventions

Type	Name	Description
DRUG	belinostat	300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1
DRUG	5-Fluorouracil (5-FU)	250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion.

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-03-01
• Completion: 2008-06-01
• First posted: 2006-12-19
• Last updated: 2015-07-08

Locations

3 sites across 1 country: United States