NCT00060151

GW786034 in Treating Patients With Advanced Solid Tumors

A Phase I, Open Label, Multiple Dose, Dose Escalation Study OF GW786034 In Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: GW786034 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and by stopping blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of GW786034 in treating patients with advanced solid tumors.

Detailed description

OBJECTIVES: * Determine the safety and tolerability of GW786034 in patients with advanced solid tumors. * Determine the maximum tolerated dose of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine the clinical response in patients treated with this drug. * Evaluate the effect of this drug on biomarkers of angiogenesis activity in order to estimate activity and to determine the minimum biologically active dose in these patients. OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients receive oral GW786034 twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 2-6 patients receive escalating doses of GW786034 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 21 days. PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	pazopanib hydrochloride

Timeline

• Start date: 2002-12-01
• Completion: 2009-06-01
• First posted: 2003-05-07
• Last updated: 2013-09-20

Locations

2 sites across 1 country: United States