This open-label, multi-center, three-period, one sequence study will investigate the effect of ketoconazole on the pharmacokinetics of vemurafenib in patients 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. Patients will receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in Periods B and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 19 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
multiple doses of ketoconazole in Period B and C
single dose of vemurafenib in Period A and C
Pharmacokinetics: Area under the concentration time curve
Time frame: Approximately 19 days
Pharmacokinetics: Maximum plasma concentration
Time frame: Approximately 19 days
Pharmacokinetics: Time to maximum plasma concentration
Time frame: Approximately 19 days
Pharmacokinetics: Terminal half-life
Time frame: Approximately 19 days
Pharmacokinetics: Apparent clearance
Time frame: Approximately 19 days
Safety: Incidence of adverse events
Time frame: Approximately 19 days
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