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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1
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.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of Nebraska
Omaha, Nebraska, United States
Portsmouth Regional Hospital Hematology/Oncology Clinic
Portsmouth, New Hampshire, United States
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
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