Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX

A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors

The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer

Inclusion Criteria:

• Patients eligible for FOLFIRI or FOLFOX therapy
• ECOG performance status score 0-1
• At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
• At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
• No maximum age for Study Arm A (FOLFOX)
• 18-65 years of age for Study Arm B (FOLFIRI)

Exclusion Criteria:

• Treatment with other TKIs within the past 4 weeks
• Active inflammatory bowel disease
• Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
• History of thromboembolism
• Severe unmanageable diarrhea
• Uncontrolled or significant cardiovascular disease