drugset / Trial / NCT01765543
A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)
NaSingle-groupOpen-labelTreatment
Summary
This open-label, multi-center, three-period, one-sequence study will investigate the effect of rifampin on the PK of vemurafenib in participants with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study GO28399 (NCT01739764).
Timeline
- Start
- 2013-07
- Primary completion
- 2015-11
- Completion
- 2015-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rifampin | Small molecule | 600 mg | Oral |
| Subject | Vemurafenib | Small molecule | 960 mg | Oral |