Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354250
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2006-07-19
Brief Title:
Ispinesib in Treating Patients With Metastatic or Unresectable Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of SB-715992 NSC-727990 IND-70273 in Advanced Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase II trial is studying how well ispinesib works in treating patients with metastatic or unresectable kidney cancer Ispinesib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess the efficacy of SB-715992 in patients with advanced renal cell cancer who have received at least one prior therapy This will be achieved by a multi-center single arm phase II study to evaluate the proportion of patients who achieve a complete or partial response with this agent
SECONDARY OBJECTIVES
I To assess the overall survival II To assess the time to progression III To evaluate the qualitative and quantitative toxicities of this regimen
OUTLINE This is a multicenter study
Patients receive ispinesib SB-715992 IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 3 years
I To assess the efficacy of SB-715992 in patients with advanced renal cell cancer who have received at least one prior therapy This will be achieved by a multi-center single arm phase II study to evaluate the proportion of patients who achieve a complete or partial response with this agent
SECONDARY OBJECTIVES
I To assess the overall survival II To assess the time to progression III To evaluate the qualitative and quantitative toxicities of this regimen
OUTLINE This is a multicenter study
Patients receive ispinesib SB-715992 IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 3 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM62201 | NIH | None | httpsreporternihgovquickSearchN01CM62201 |
| 14577A | None | None | None |