Safety Study of S-CKD602 in Patients With Advanced Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00177281|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: S CKD602||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate the Safety and Pharmacokinetics of S-CKD602 in Patients With Advanced Malignancies|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177281
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Ramesh K Ramanathan, MD||University of Pittsburgh|