Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 4:59 PM
Study NCT ID:
NCT00354250
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2006-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ispinesib in Treating Patients With Metastatic or Unresectable Kidney Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 14577A | None | None | View | |
| N01CM62201 | NIH | None | https://reporter.nih.gov/quic… | View |