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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01773785
Other study ID # SPI-1620-12-202
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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