NCT00093730CompletedPhase 1
Phase I Study Of BMS-599626 In Patients With Advanced Solid Malignancies That Express Her2
Jonsson Comprehensive Cancer Center1 site in 1 country9 target enrollmentStarted: August 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- maximum tolerated dose of BMS-599626
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BMS-59926
Experimental
Intervention: BMS-59926 (Drug)
Outcomes
Primary Outcomes
maximum tolerated dose of BMS-599626
Time Frame: 28 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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