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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00093730 |
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.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: BMS-599626 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Study Of BMS-599626 In Patients With Advanced Solid Malignancies That Express Her2 |
Estimated Enrollment: | 60 |
Study Start Date: | August 2004 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary solid (i.e., non-hematologic) tumor
Radiographic or tissue confirmation of metastatic disease
HER2/neu overexpression (1+, 2+, or 3 +) by immunohistochemistry
Measurable or non-measurable disease
No known brain metastasis
Patients with controlled brain metastasis with no disease progression 60 days after prior therapy and no neurologic signs or symptoms are allowed
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No history of second- or third-degree heart block
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study ID Numbers: | CDR0000389510, UCLA-0404066-01, BMS-CA181002 |
Study First Received: | October 6, 2004 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00093730 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |