drugset / Trial / NCT00613145
Study of the Pharmacokinetics/Safety of Sorafenib + Capecitabine in Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase I, randomized, safety and pharmacokinetic (PK) study of sorafenib given in combination with capecitabine. The study will enroll two simultaneous cohorts; patients will be randomly assigned to either Cohort A or Cohort B. A third cohort (C) may be added to the protocol at a later date.
Timeline
- Start
- 2008-02
- Primary completion
- 2009-05
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 750 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Sorafenib | Small molecule | 400 mg | Oral |