A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

A Phase I Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.

Inclusion Criteria:

• Men and women 18 and older
• Diagnosis of any solid tumor
• ECOG performance status score 0-1
• Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment
• Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)

Exclusion Criteria:

• Treatment with other TKIs within the past 4 weeks
• Patients with brain metastasis
• Patients with centrally located squamous cell carcinoma of the lung
• Major gastrointestinal surgery which may affect absorption of the drug
• Any surgery within last 4 weeks
• History of thromboembolism
• Severe unmanageable diarrhea
• Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)
• Part B/Cohort I erlotinib-naive subjects
• Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)