Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-03-29 @ 10:31 AM
Study NCT ID:
NCT00095992
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
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:
True
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?: