Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095992
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-11-09
Brief Title:
SB-715992 in Treating Patients With Locally Advanced Recurrent or Metastatic Liver Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study Of SB-715992 NSC 727990 In Patients With Locally Advanced Recurrent Or Metastatic Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2020-04
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 locally advanced recurrent or metastatic liver cancer
PURPOSE This phase II trial is studying how well SB-715992 works in treating patients with locally advanced recurrent or metastatic liver cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of SB-715992 in terms of response rate and stable disease rate in patients with locally advanced recurrent or metastatic hepatocellular carcinoma
Determine the toxicity 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 of this drug in these patients
Correlate tumor expression of β-tubulin and kinesin spindle protein with clinical outcomes in patients treated with this drug
OUTLINE This is a non-randomized 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 Patients with ongoing stable or responding disease are followed every 3 months until relapse
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 12-14 months
Determine the efficacy of SB-715992 in terms of response rate and stable disease rate in patients with locally advanced recurrent or metastatic hepatocellular carcinoma
Determine the toxicity 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 of this drug in these patients
Correlate tumor expression of β-tubulin and kinesin spindle protein with clinical outcomes in patients treated with this drug
OUTLINE This is a non-randomized 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 Patients with ongoing stable or responding disease are followed every 3 months until relapse
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 12-14 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000391839 | OTHER | PDQ | None |
| CAN-NCIC-IND168 | OTHER | None | None |