drugset / Trial / NCT02267707
Pharmacokinetic and Safety Study of Nab®-Paclitaxel (ABI-007) Plus Gemcitabine in Subjects With Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubinemia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety and pharmacokinetic profile of nab®-paclitaxel (ABI-007) plus gemcitabine in subjects with advanced pancreatic cancer who have cholestatic hyperbilirubinemia secondary to bile duct obstruction.
Timeline
- Start
- 2015-05-27
- Primary completion
- 2016-02-10
- Completion
- 2016-02-10
Outcome
Outcome not reported
Stopped: “Study population more infrequent than estimated. No study-related safety issues and no safety concerns were identified for the study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 600 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |