BMS-599626 in Patients With Advanced Solid Malignancies

Completed · Phase 1

Conditions studied: Cancer, Metastases

In brief

The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21 days with a 7 day rest period in patients with cancer who no longer benefit from other commonly used treatments. The study will also test for other proteins that may be affected by BMS-599626; and the level of study drug in the blood will be studied.

Key facts

Study ID

NCT00095537

Run by

Bristol-Myers Squibb

People needed

60

Starts

2004-03-01

Last updated by the study team

2010-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of metastatic cancer that has progressed on currently available therapies;
• At least 3 month life expectancy;
• Primary cancer must be solid (non-hematologic);
• Adequate bone marrow, liver \& kidney function;
• Negative pregnancy test.

You may not qualify if…

• Serious, uncontrolled medical disorder;
• Individuals not willing or able to use an acceptable method to avoid pregnancy for the entire study period and for at least 3 months after the study;
• Pregnant or breastfeeding women;
• Patients with known brain metastasis;
• Uncontrolled or significant cardiovascular disease;
• Anticancer therapy within 2-6 weeks prior to study drug (depending on the therapy)

Where it is running

• Local Institution — Scottsdale, Arizona, United States
• Local Institution — Tucson, Arizona, United States
• Local Institution — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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