Futility reasons after Independent Data Monitoring Committee interim analysis

The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.

Inclusion Criteria:

• Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach
• 18 years or older
• Life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3
• Willing and able to sign informed consent
• Sexually active men and women must use an accepted and effective method of contraception (including barrier contraception with spermicide)
• Women of child-bearing age must have a negative pregnancy test
• Laboratory criteria

Exclusion Criteria:

• Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study)
• Unstable angina, or class III or IV New York Heart Association heart disease
• Central nervous system metastases
• Uncontrolled diabetes mellitus
• Uncontrolled seizure disorder
• Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment
• Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation
• Pregnant or breast-feeding
• A known history of human immunodeficiency virus (HIV) infection