A Phase I Study to Evaluate the Safety and Pharmacokinetics of S-CKD602 in Patients With Advanced Malignancies
The main purposes of this study are:
To determine the maximum tolerated dose (highest dose that can safely be given to subjects)
of S CKD602 when given every three weeks.
To determine the incidence and severity of toxicity (side-effects) of S CKD602 when given
every three weeks.
To determine a subject's body handles the drug (pharmacokinetics) following administration
of S CKD602.
In addition to the above, we would also like to analyze how the genes (material inside each
cell that is responsible for cell functioning and appearance) found in a subject's blood
affect how the study drug S-CKD602 is broken down in a subject's body. This process is
referred to as “metabolic genotyping analyses”. This evaluation is performed using a blood
sample and is optional.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of S CKD602 when given every three weeks.
Ramesh K Ramanathan, MD
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
03-052
NCT00177281
September 2003
April 2008
Name | Location |
---|---|
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |