A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma

Inclusion Criteria:

- Male or female patients >= 18 years old

- Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive
for the BRAFV600 mutation or other malignant tumor type that harbors a
V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600
mutation test or a DNA sequencing method, and who have no acceptable standard
treatment options

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

- Life expectancy >= 12 weeks

- Full recovery from the effects of any major surgery or significant traumatic injury
within 14 days prior to the first dose of study treatment

- Adequate hematologic and end organ function

- Female patients of childbearing potential and male patients with partners of
childbearing potential must agree to always use two effective methods of
contraception

- Negative serum pregnancy test within 7 days prior to commencement of dosing in women
of childbearing potential

Exclusion Criteria:

- Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of first dose
of study drug

- Requirement for immediate or urgent treatment with daily vemurafenib and for whom the
intermittent schedule of vemurafenib employed during the 19-day period for this trial
is not clinically acceptable

- Allergy or hypersensitivity to components of the vemurafenib formulation

- Experimental therapy within 4 weeks prior to first dose of study drug

- Major surgical procedure or significant traumatic injury within 14 days prior to
first dose of study drug or anticipation of the need for major surgery during study
treatment

- Prior anti-cancer therapy within 28 days before the first dose of study drug

- History of clinically significant cardiac or pulmonary dysfunction

- History of symptomatic congestive heart failure of any New York Heart Association
class or serious cardiac arrhythmia requiring treatment

- History of myocardial infarction within 6 months prior to first dose of study drug

- Current dyspnea at rest, owing to complications of advanced malignancy or any
requirement for supplemental oxygen to perform activities of daily living

- History of congenital long QT syndrome or QTc > 450 ms

- Active central nervous system lesions

- Uncontrolled or poorly controlled diabetes

- Current severe, uncontrolled systemic disease