Clinical trial · Interventional
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer
NCT01773785CI-TRIAL-00054429terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.
Summary
Brief summary (as posted)
The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| SPI-1620 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SPI-1620 & Docetaxel
- description
- 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.
- interventionNames
- Drug: SPI-1620
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 18 months
Secondary outcomes (4)
- measure
- Overall response rate
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.