Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer

Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer

The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.

Inclusion Criteria:

• Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
• Evaluable disease
• ECOG PS ≤ 2
• Adequate bone marrow, liver and renal function

Exclusion Criteria:

• Treatment with more than one prior chemotherapy regimen
• Known, uncontrolled CNS metastases
• Baseline peripheral neuropathy ≥ grade 2.
• Significant circulatory disorders in the past 6 months
• Concomitant use of phosphodiesterase inhibitors