This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to
investigate the effect of itraconazole and rifampin on the PK of vemurafenib following
multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with
unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation,
or other malignant tumor types that harbor a V600-activating mutation of BRAF where the
participant has no acceptable standard treatment options.
Inclusion Criteria:
- Participants with age greater than or equal to (>=) 18 years with either unresectable
Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or
other malignant tumor types that harbor a V600-activating mutation of BRAF
- Eastern Cooperative Oncology Group Performance Status 0 to 2
- Life expectancy >=12 weeks
- Adequate hematologic and end organ function obtained within 2 weeks prior to first
dose of study drug
- Female participants of childbearing potential and male participants with partners of
childbearing potential must agree to always use two effective methods of
contraception including at least one method with a failure rate of <1% per year
during the course of the study and for at least 6 months after completion of study
treatment
- Negative serum pregnancy test within 7 days prior to commencement of dosing in women
of childbearing potential
- Absence of any psychological, familial, sociological, or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule
Exclusion Criteria:
- Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Study Day
1 of Period A
- Allergy or hypersensitivity to components of the vemurafenib formulation
- Experimental therapy within 4 weeks prior to first dose of study drug treatment on
Study Day 1 of Period A
- Major surgical procedure or significant traumatic injury within 14 days prior to
first dose of study drug treatment on Study Day 1 of Period A, or anticipation of the
need for major surgery during study treatment
- Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy)
within 28 days (6 weeks for nitrosoureas or mitomycin C, and 14 days for hormonal
therapy or kinase inhibitors) before the first dose of study treatment on Study Day 1
of Period A.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Area under the concentration-time curve From Time 0 to 12 Hours Postdose (AUC0-12)
Maximum observed concentration (Cmax)
Time to maximum concentration (Tmax)
