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

Stopped early · Phase 2

Conditions studied: Biliary Cancer

In brief

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

Key facts

Study ID

NCT01773785

Run by

Spectrum Pharmaceuticals, Inc

People needed

30

Starts

2013-04-01

Expected to finish

2015-09-01

Last updated by the study team

2021-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Associates in Oncology and Hematology — Chattanooga, Tennessee, United States
• The West Clinic — Memphis, Tennessee, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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