Safety Study of S-CKD602 in Patients With Advanced Malignancies
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177281
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Ramesh K Ramanathan, MD||University of Pittsburgh|