Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer
NCT ID: NCT01773785
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2013-04-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SPI-1620 & Docetaxel
Patients will receive 11 μg/m2 of SPI-1620 intravenously over one minute. Ten minutes after (±2 min) SPI-1620 administration, patients will receive docetaxel 75 mg/m2 intravenous. This regimen will be repeated every 3-weeks cycles until progression or intolerable toxicity.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Evaluable disease
* ECOG PS ≤ 2
* Adequate bone marrow, liver and renal function
Exclusion Criteria
* Known, uncontrolled CNS metastases
* Baseline peripheral neuropathy ≥ grade 2.
* Significant circulatory disorders in the past 6 months
* Concomitant use of phosphodiesterase inhibitors
18 Years
ALL
No
Sponsors
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Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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SPI-1620-12-202
Identifier Type: -
Identifier Source: org_study_id