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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Biliary Cancer

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Trial Information

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Caio Rocha-Lima, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami

Authority:

United States: Food and Drug Administration

Study ID:

SPI-1620-12-202

NCT ID:

NCT01773785

Start Date:

April 2013

Completion Date:

July 2015

Related Keywords:

  • Biliary Cancer
  • Biliary Tract Neoplasms

Name

Location
University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center Miami, Florida  33136