BMS-599626 in Treating Patients With Metastatic Solid Tumors
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.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study Of BMS-599626 In Patients With Advanced Solid Malignancies That Express Her2|
- maximum tolerated dose of BMS-599626 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2004|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093730
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Mark D. Pegram, MD||Jonsson Comprehensive Cancer Center|