Study Stopped
The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer
1 other identifier
interventional
30
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2013
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2013
CompletedFirst Posted
Study publicly available on registry
January 23, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 13, 2021
October 1, 2021
2.4 years
January 14, 2013
October 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival
18 months
Secondary Outcomes (4)
Overall response rate
18 months
Overall survival
18 months
Duration of Response
12 months
Safety of SPI-1620 when administered in combination with docetaxel
12 months
Study Arms (1)
SPI-1620 & Docetaxel
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Washington University School of Medicine
St Louis, Missouri, United States
Associates in Oncology and Hematology
Chattanooga, Tennessee, 37421, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2013
First Posted
January 23, 2013
Study Start
April 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 13, 2021
Record last verified: 2021-10