Safety Study 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study to Evaluate the Safety and Pharmacokinetics of S-CKD602 in Patients With Advanced Malignancies|
- To determine the maximum tolerated dose of S CKD602 when given every three weeks.
- To determine the incidence and severity of toxicity of S CKD602 when given every three weeks.
- To determine the pharmacokinetics of CKD 602 following administration of S CKD602.
|Study Start Date:||September 2003|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
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.
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Ramesh K Ramanathan, MD||University of Pittsburgh|