NCT00093730

BMS-599626 in Treating Patients With Metastatic Solid Tumors

Phase I Study Of BMS-599626 In Patients With Advanced Solid Malignancies That Express Her2

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: BMS-599626 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-599626 in treating patients with metastatic solid tumors.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose, biologically active dose, and recommended phase II dose(s) of BMS-599626 in patients with metastatic HER2/neu-overexpressing primary solid tumors. Secondary * Determine the safety and tolerability of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine the effect of this drug on biomarkers and predictive markers of HER1 and HER2 in skin and tumor in these patients. * Evaluate tumor metabolic activity in response to this drug in these patients. * Determine, preliminarily, evidence of anti-tumor activity of this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive oral BMS-599626 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-599626 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. Once the MTD is determined, 20 patients are treated at that dose level. PROJECTED ACCRUAL: Approximately 3-60 patients will be accrued for this study within 1 year.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	BMS-59926

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-04-01
• First posted: 2004-10-08
• Last updated: 2012-10-04

Locations

1 site across 1 country: United States