BMS-599626 in Patients With Advanced Solid Malignancies

Phase I Study of BMS-599626 in Patients With Advanced Solid Malignancies, Including Malignancies That Express HER2 at the Maximum Tolerated Dose and/or Recommended Phase II Dose

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)