A Pharmacokinetic Study of RO5185426 in Combination With a Drug Cocktail in Patients With Metastatic Melanoma
Status:
Completed
Trial end date:
2012-02-29
Target enrollment:
Participant gender:
Summary
This open-label single-arm study will evaluate the effect of RO5185426 [RG7204; PLEXXIKON:
PLX4032] on the pharmacokinetics of five CYP450 substrates (caffeine, warfarin + vitamin K,
omeprazole, dextromethorphan, midazolam) administered as a drug cocktail to patients with
metastatic melanoma. The study will also evaluate efficacy and safety of RO5185426. On day 1,
patients will receive the drug cocktail. On days 6 to 19, patients will receive RO5185426
twice daily. On day 20, patients will receive RO5185426 and the drug cocktail and on days 21
to 25, patients will receive RO5185426. Assessments will be made at regular intervals during
the dosing periods and at follow-up. Patients may continue on study treatment (RO5185426)
until the development of progressive disease or unacceptable toxicity. Target sample size
<50.