drugset / Trial / NCT02106845
Effect of Regorafenib on Digoxin and Rosuvastatin in Patients With Advanced Solid Malignant Tumors.
Non-randomizedCrossoverOpen-labelTreatment
Summary
Evaluate the effect of regorafenib on the pharmacokinetics of digoxin (P-gp substrate : P-glycoprotein) and rosuvastatin (BCRP substrate: Breast cancer resistant protein) by comparing their Area under time curve (AUC(0-24)) and maximum drug concentration (Cmax) on Day -7 and Cycle 1 or Cycle 2 Day 15 of regorafenib in cancer patients
Timeline
- Start
- 2014-04-22
- Primary completion
- 2015-04-27
- Completion
- 2018-06-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Digoxin | Other / unclassified | 0.5 mg | Oral |
| Subject | Regorafenib | Small molecule | 160 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 5 mg | Oral |