Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096499
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2004-11-09
Brief Title:
SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel
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 Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Drugs used in chemotherapy such as SB-715992 work in different ways to stop tumor cells from dividing so they stop growing or die This phase II trial is studying how well SB-715992 works in treating patients with metastatic prostate cancer that did not respond to docetaxel or paclitaxel
Detailed Description:
PRIMARY OBJECTIVES
I Determine the prostate-specific antigen response to SB-715992 in patients with hormone-refractory androgen-independent metastatic prostate cancer that failed prior taxane-based chemotherapy
SECONDARY OBJECTIVES
I Determine the median overall survival and median progression-free survival of patients treated with this drug
II Determine the objective response rate confirmed and unconfirmed complete and partial response in patients with measurable disease treated with this drug
III Determine the qualitative and quantitative toxic effects of this drug in these patients
IV Determine preliminarily the pharmacokinetics and mechanism of activity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive SB-715992 IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 13-27 months
I Determine the prostate-specific antigen response to SB-715992 in patients with hormone-refractory androgen-independent metastatic prostate cancer that failed prior taxane-based chemotherapy
SECONDARY OBJECTIVES
I Determine the median overall survival and median progression-free survival of patients treated with this drug
II Determine the objective response rate confirmed and unconfirmed complete and partial response in patients with measurable disease treated with this drug
III Determine the qualitative and quantitative toxic effects of this drug in these patients
IV Determine preliminarily the pharmacokinetics and mechanism of activity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive SB-715992 IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 13-27 months
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 |
|---|---|---|---|
| CDR0000393206 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-S0418 | None | None | None |
| U10CA032102 | NIH | None | None |