Cancer Clinical Trial
Official title:
A Phase I Study to Evaluate the Safety and Pharmacokinetics of S-CKD602 in Patients With Advanced Malignancies
The purpose of this research study is to evaluate a new anti-cancer drug called S CKD602, developed by ALZA Corporation. The drug is investigational and not approved by the Food and Drug administration (FDA). The side effects (the way the drug acts in your body) and the effect it has on your disease will be studied.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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