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

Biliary Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01773785
• Other study ID #: SPI-1620-12-202
• Status: Terminated
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2021
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• SPI-1620
SPI-1620 11 µg/m2 will be given intravenously over 1 minute.
• Docetaxel
Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		18 months
Secondary	Overall response rate		18 months
Secondary	Overall survival		18 months
Secondary	Duration of Response		12 months
Secondary	Safety of SPI-1620 when administered in combination with docetaxel	Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed	12 months