NCT00095992

SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer

A Phase II Study Of SB-715992 (NSC 727990) In Patients With Locally Advanced, Recurrent Or Metastatic Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	ispinesib	SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks

Timeline

• Start date: 2005-03-08
• Primary completion: 2006-09-26
• Completion: 2008-09-22
• First posted: 2004-11-09
• Last updated: 2023-08-04

Locations

4 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study