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

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Docetaxel

Criteria

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