Biliary Cancer
Conditions
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.
Interventions
DRUGSPI-1620
SPI-1620 11 μg/m2 will be given intravenously over 1 minute.
DRUGDocetaxel
Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.
Sponsors
Spectrum Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed |
Countries
United States
Outcome results
None listed