Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095953
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2004-11-09
Brief Title:
SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
Sponsor:
NCIC Clinical Trials Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of SB-715992 NSC 727990 in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2011-09
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:
RATIONALE Drugs used in chemotherapy such as SB-715992 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well SB-715992 works in treating patients with metastatic or recurrent malignant melanoma
PURPOSE This phase II trial is studying how well SB-715992 works in treating patients with metastatic or recurrent malignant melanoma
Detailed Description:
OBJECTIVES
Determine the efficacy of SB-715992 in terms of response rate in patients with previously untreated metastatic or recurrent malignant melanoma
Determine the toxic effects of this drug in these patients
Determine the early progression rate and response duration in patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
Correlate pharmacokinetics with safety and efficacy endpoints of this drug in these patients
Correlate β-tubulin and kinesin spindle protein expression in tumor tissue with clinical outcomes in patients treated with this drug
OUTLINE This is a nonrandomized 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
All patients are followed at 4 weeks after completion of protocol therapy Patients with ongoing complete response partial response or stable disease are followed every 3 months thereafter until relapse
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 12-14 months
Determine the efficacy of SB-715992 in terms of response rate in patients with previously untreated metastatic or recurrent malignant melanoma
Determine the toxic effects of this drug in these patients
Determine the early progression rate and response duration in patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
Correlate pharmacokinetics with safety and efficacy endpoints of this drug in these patients
Correlate β-tubulin and kinesin spindle protein expression in tumor tissue with clinical outcomes in patients treated with this drug
OUTLINE This is a nonrandomized 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
All patients are followed at 4 weeks after completion of protocol therapy Patients with ongoing complete response partial response or stable disease are followed every 3 months thereafter until relapse
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 12-14 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 |
|---|---|---|---|
| CDR0000391842 | OTHER | PDQ | None |
| CAN-NCIC-IND169 | None | None | None |