A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour
This is a multicentre clinical study conducted in Belgium and in The Netherlands. The study
is a phase I divided in 2 steps: The first step is a dose escalation to define the RD. At
the second step the PK profile of oral CP-4126 will be compared with the PK profile of IV
gemcitabine. In addition, the study is conducted to characterize the tolerability of oral
CP-4126, to evaluate its bioavailability, and to make a preliminary assessment of antitumor
activity in patients with solid tumours.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Step 1: MTD of oral CP-4126 in patients with advanced solid tumours, followed by establishing the recommended dose
6 months
No
Ahmad H Awada, MD
Principal Investigator
Institute Jules Bordet
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
CP4126-111
NCT00778128
October 2008
April 2010
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