Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177281
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2005-09-12
Brief Title:
Safety Study of S-CKD602 in Patients With Advanced Malignancies
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety and Pharmacokinetics of S-CKD602 in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 subjects 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 subjects blood affect how the study drug S-CKD602 is broken down in a subjects body This process is referred to as metabolic genotyping analyses This evaluation is performed using a blood sample and is optional
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 subjects 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 subjects blood affect how the study drug S-CKD602 is broken down in a subjects body This process is referred to as metabolic genotyping analyses This evaluation is performed using a blood sample and is optional
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None